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Feasibility of an Acute Physical Exercise Before Treatment Infusion for Metastatic Lung Cancer Patients (ERICA)

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exercise arm :
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Carcinoma, Non-Small-Cell Lung focused on measuring Lung Cancer, Lung Neoplasm, Metastasis, Acute exercise, Immunotherapy, Connected devices

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 80 years old,
  • Having a newly metastatic non-small-cell lung cancer (NSCLC) without an EGFR/ALK alteration diagnosis,
  • Being scheduled to receive a 1st line intravenous chemotherapy (Cisplatin and Pemetrexed or Carboplatin and Pemetrexed or Taxol and Carboplatin), and immunotherapy (monoclonal anti-PD-1 and anti-PD-L1 antibodies : Pembrolizumab) treatment NB : patients who have previously received one or more treatments other than chemotherapy (e.g. targeted therapy) and must start their first chemotherapy are eligible,
  • Treated in Centre Leon Berard,
  • Having an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2,
  • Being voluntary and available to get involved throughout the study duration,
  • Being able to engage in Physical Activity with a medical certificate attested by one of the investigators clinical oncologist or the referring oncologist,
  • Affiliated with a social security scheme,
  • Having dated and signed an informed consent.
  • Able to read, write and understand French

Exclusion Criteria:

  • Patient with unstable bone metastases or unconsolidated pathologic fractures, Having a central nervous system impairment with neurological disorder avoids the physical exercise practice on a cycle ergometry,
  • Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or cancer in complete remission for more than 5 years),
  • Having severe undernutrition defined according to the Haute Autorité de Santé (i.e. , for an adult aged ≥18 years and < 70 : BIM ≤ 17 or weight loss ≥ 10% in 1 month or ≥15% in 6 months or ≥ 15% compared to the usual weight before the disease diagnosis or albuminemia < 30 g/l ; for an adult aged ≥70 years : BIM < 18 or weight loss ≥ 10% in 1 month or ≥15% in 6 months or an albuminemia < 30 g/l),
  • Having a severe amenia (hemoglobin ≤ 8 g/dl) during the 30 last days prior inclusion,
  • Presenting cardiovascular history or any cardiovascular risk: chronic coronary (or poorly balanced), artery disease, cardiac arrhythmia, symptomatic heart disease, uncontrolled or untreated hypertension, heart attack diagnosed within the last 6 months, coronary angioplasty with or without stent less than 6 months old, coronary artery bypass surgery less than 12 months old, history of poorly balanced type 2 diabetes,
  • In case of diabetes: Glycated hemoglobin (HbA1c) > 7% (in the last 3 months),
  • Stage IV Chronic Obstructive Pulmonary Disease (FEV1 < 30%),
  • Patient with a contraindication to the proposed physical exercise in the study (orthopedic disorder likely to impede walking and pedaling such as disabling coxarthrosis or gonarthrosis, operated or not),
  • Already included in a PA study,
  • Cannot be followed for medical, social, family, geographical or psychological reasons, for the duration of the intervention (3 months) and then for the duration of the post-intervention follow-up (3 months),
  • Patient under legal protection measure (under guardianship, curatorship, safeguard of justice),
  • Deprived of liberty by judicial or administrative decision,
  • Pregnant patient.

Sites / Locations

  • Centre Léon BérardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise arm :

Control arm

Arm Description

Patient randomized to the Exercise arm will receive physical activity recommendations at inclusion and nutritional assessment will be carried out during the first and last treatment cure. Patients will receive an acute physical exercise just before immunotherapy and chemotherapy infusion.They will have a home walking program and will have to wear an activity tracker during the 3 months of intervention. 3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place before exercise (1), after exercise (2) and 12 hours after the start of treatment (3).

Patients will receive physical activity recommendations at inclusion and a nutritional assessment will be carried out during the first and last treatment cure. They will receive the usual care and standard treatment protocol (immunotherapy and chemotherapy). 3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment (3).

Outcomes

Primary Outcome Measures

Investigate the feasibility of an acute physical exercise during the immunotherapy/chemotherapy preinfusion
Ratio of the number of acute physical exercise sessions immunotherapy/chemotherapy preinfusion performed by"exercise" group patient / number of acute physical exercise sessions planned

Secondary Outcome Measures

Investigate the physical activity fitness (sub-maximum endurance test)
Sub-maximum endurance test on an ergocycle
Investigate the lower strength muscular function change
Maximum isometric force of the knee extensors
Investigate the maximum isometric upper limb strength change
Hand dynamometer
Investigate the Physical Activity level change
The PA level will be measured by the Godin Leisure-Time Physical Activity Questionnaire (GLTAPQ). The GLTAPQ is a 4-item self-administered questionnaire with the first three questions designed to obtain information on the number of times an individual engages in light, moderate and intense "leisure-time PA" periods of at least 15 minutes during a typical week. The scoring of the GSLTPAQ is the "LSI" (Leisure Score Index) is obtained using the following formula: (light PA frequency × 3) + (moderate PA frequency × 5) + (vigorous PA frequency × 9). People with a moderate to high LSI ≥ 24 are classified as active, while people reporting a moderate to high LSI ≤ 23 are classified as insufficiently active (estimated energy expenditure < 14 Kcal/kg/week).
Investigate the patient anthropometrics change
Weight in kilograms
Investigate the patient anthropometrics change
Hip circumference in centimeters
Investigate the patient anthropometrics change
Waist circumference in centimeters
Investigate the patient anthropometrics change
BMI (weight/height²)
Investigate the patient health-related quality of life change
Quality of life will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). Quality of life specific to lung cancer will be assessed by the 13-item module: The Quality Of Life Questionnaire - Lung Cancer 13 (QLQ-LC13). The QLQ-LC13 self-questionnaire is an additional measure of the symptoms and side effects experienced by lung cancer patients who receive non-surgical treatment.
Investigate the patient health-related quality of life specific to lung cancer change
Quality of life specific to lung cancer will be assessed by the 13-item module: The Quality Of Life Questionnaire - Lung Cancer 13 (QLQ-LC13). The QLQ-LC13 self-questionnaire is an additional measure of the symptoms and side effects experienced by lung cancer patients who receive non-surgical treatment.
Investigate the fatigue change
Fatigue will be assessed by the EORTC-QLQ module measuring cancer-related fatigue (EORTC QLQ-FA12). This self-questionnaire includes 12 items that assess physical, cognitive and emotional fatigue related to cancer. Participants will respond on a Likert scale ranging from "not at all" to "a lot". All scores will be transformed into a scale from 0 to 100, with a higher score indicating a higher degree of fatigue.
Investigate the sleep quality change
The perceived quality of sleep is assessed by the Insomnia Severity Index (ISI) which measures the severity of insomnia. The questionnaire consists of 7 items rated on a 5-point scale ranging from 0 ("none") to 4 ("very severe"). This self-questionnaire makes it possible to evaluate the severity of the patient's sleep difficulties (initial, maintenance, morning insomnia), the degree of sleep dissatisfaction, the level of interference with daily functioning, the degree of appearance of sleep difficulties and the level of anxiety related to insomnia. The total score of the items varies between 0 and 28. A high score indicates greater sleep difficulties.
Investigate the impact of social vulnerability
Social vulnerability will be assessed by the EPICES score (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé). By adding up the points of the 11 binary questions ("Yes"/"No") of the self-questionnaire we obtain the so-called EPICES score. This quantitative score varies from 0 "no precariousness" to 100 "highest precariousness".
Investigate the muscle mass and sarcopenia
CT scans
Investigate the immune biomarkers change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following immune biomarkers will be assay : Natural Killer cells, B lymphocytes, T lymphocytes, monocytes, sub-populations of dendritic cells on frozen PBMC
Investigate the Activin change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the TNF-alpha change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the IL-1béta change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the IL-6 change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the Follistatin (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the GDF5 (BMP14) (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the GDF15 (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the IL-10 (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the IL-15 (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the NH3 (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the Aminogramme (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the CRP (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the IFN-gamma change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the Cortisol change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the Myostatin change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the Advanced oxidation protein products (AOPP) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the Superoxide dismutase (SOD) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the catalase (CAT) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the malondialdehyde (MDA) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).
Investigate the glutathione peroxidase (GPX) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).
Investigate the Xanthine Myeloperoxidase (MPO) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).
Investigate the Xanthine oxidase (XO) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).
Proportion of patients who have severe toxicity (grade >2)
Occurence of severe toxicity (grade > 2) according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Number of delayed or cancelled treatment sessions and relative dose-intensity (RDI) for patients with grade ≥ 3 chemotherapy-related toxicities, calculated as the ratio of the "delivered" dose-intensity to the "expected" dose-intensity.
Progression free survival
Period from the date of randomization to the date of event defined as disease progression or death from any cause
Acceptability of the study
Ratio of the number of patients included / number of eligible patients
Tracker activity acceptability
Number of days the activity tracker is worn / number of days in the programme
Safety of the intervention
Number, type and timing of adverse events due to program
Adherence of the intervention
number of steps at home realized / number of steps at home prescribed (only in the intervention arm)
Investigate the Physical Activity level change
Daily number of step prescription (only in the intervention arm)
Investigate the glucose change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the insulin change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the lactat change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the PCR change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Investigate the HIF-1 change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).

Full Information

First Posted
December 8, 2020
Last Updated
December 15, 2021
Sponsor
Centre Leon Berard
Collaborators
Claude Bernard University, Lyon Cancer Research Centre, Hospices Civils de Lyon, Inter-university Laboratory of Human Movement Biology
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1. Study Identification

Unique Protocol Identification Number
NCT04676009
Brief Title
Feasibility of an Acute Physical Exercise Before Treatment Infusion for Metastatic Lung Cancer Patients
Acronym
ERICA
Official Title
Feasibility of an Acute Physical Exercise Before Immunotherapy and Chemotherapy Infusion for Metastatic Non-small-cell Lung Cancer Patients: Protocol ERICA Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
September 10, 2022 (Anticipated)
Study Completion Date
December 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
Collaborators
Claude Bernard University, Lyon Cancer Research Centre, Hospices Civils de Lyon, Inter-university Laboratory of Human Movement Biology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Because of metastatic Non-Small Cell Lung Cancer (mNSCLC) and its treatments, patients suffer from numerous symptoms such as dyspnea, muscle atrophy, pain, fatigue, loss of appetite, altered physical condition and lung function, which may further impair the patient's overall condition. Nevertheless, it has been suggested that physical exercise could improve response to treatment at the clinical level due to its known effects on the immune system. Moreover, preclinical studies have shown that exercise performed during chemotherapy administration could result in physiological benefits such as improved intra-tumoral infusion and drug delivery. The ERICA study aims to assess the feasibility of an acute physical exercise immediately before immunotherapy and chemotherapy administration in patients with mNSCLC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Lung Cancer, Lung Neoplasm, Metastasis, Acute exercise, Immunotherapy, Connected devices

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise arm :
Arm Type
Experimental
Arm Description
Patient randomized to the Exercise arm will receive physical activity recommendations at inclusion and nutritional assessment will be carried out during the first and last treatment cure. Patients will receive an acute physical exercise just before immunotherapy and chemotherapy infusion.They will have a home walking program and will have to wear an activity tracker during the 3 months of intervention. 3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place before exercise (1), after exercise (2) and 12 hours after the start of treatment (3).
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Patients will receive physical activity recommendations at inclusion and a nutritional assessment will be carried out during the first and last treatment cure. They will receive the usual care and standard treatment protocol (immunotherapy and chemotherapy). 3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment (3).
Intervention Type
Other
Intervention Name(s)
Exercise arm :
Intervention Description
Patients will receive physical activity recommendations at inclusion. At each treatment cure, patients will receive pre-exercise nutritional recommendations and an acute physical exercise prior to immunotherapy and chemotherapy. The acute physical exercise will last 35 minutes and will be intermittent and individualized based on the results obtained by the patient during an endurance test on a ergocyle performed prior to treatment. 3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place before exercise (1), after exercise (2) and 12 hours after the start of treatment (3). A nutritional assessment will be carried out during the first and last treatment cure. They will also benefit a home walking program. These patients will have to wear an activity tracker tracker during all intervention (3 months). They will have a phone follow-up every 10 days (± 3 days) after each treatment cure for the study duration.
Primary Outcome Measure Information:
Title
Investigate the feasibility of an acute physical exercise during the immunotherapy/chemotherapy preinfusion
Description
Ratio of the number of acute physical exercise sessions immunotherapy/chemotherapy preinfusion performed by"exercise" group patient / number of acute physical exercise sessions planned
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Investigate the physical activity fitness (sub-maximum endurance test)
Description
Sub-maximum endurance test on an ergocycle
Time Frame
Baseline, 3 months
Title
Investigate the lower strength muscular function change
Description
Maximum isometric force of the knee extensors
Time Frame
Baseline, 3 months, 6 months
Title
Investigate the maximum isometric upper limb strength change
Description
Hand dynamometer
Time Frame
Baseline, 3 months, 6 months
Title
Investigate the Physical Activity level change
Description
The PA level will be measured by the Godin Leisure-Time Physical Activity Questionnaire (GLTAPQ). The GLTAPQ is a 4-item self-administered questionnaire with the first three questions designed to obtain information on the number of times an individual engages in light, moderate and intense "leisure-time PA" periods of at least 15 minutes during a typical week. The scoring of the GSLTPAQ is the "LSI" (Leisure Score Index) is obtained using the following formula: (light PA frequency × 3) + (moderate PA frequency × 5) + (vigorous PA frequency × 9). People with a moderate to high LSI ≥ 24 are classified as active, while people reporting a moderate to high LSI ≤ 23 are classified as insufficiently active (estimated energy expenditure < 14 Kcal/kg/week).
Time Frame
Baseline, 3 months, 6 months
Title
Investigate the patient anthropometrics change
Description
Weight in kilograms
Time Frame
Baseline, 3 months, 6 months
Title
Investigate the patient anthropometrics change
Description
Hip circumference in centimeters
Time Frame
Baseline, 3 months, 6 months
Title
Investigate the patient anthropometrics change
Description
Waist circumference in centimeters
Time Frame
Baseline, 3 months, 6 months
Title
Investigate the patient anthropometrics change
Description
BMI (weight/height²)
Time Frame
Baseline, 3 months, 6 months
Title
Investigate the patient health-related quality of life change
Description
Quality of life will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). Quality of life specific to lung cancer will be assessed by the 13-item module: The Quality Of Life Questionnaire - Lung Cancer 13 (QLQ-LC13). The QLQ-LC13 self-questionnaire is an additional measure of the symptoms and side effects experienced by lung cancer patients who receive non-surgical treatment.
Time Frame
Baseline, 3 months, 6 months
Title
Investigate the patient health-related quality of life specific to lung cancer change
Description
Quality of life specific to lung cancer will be assessed by the 13-item module: The Quality Of Life Questionnaire - Lung Cancer 13 (QLQ-LC13). The QLQ-LC13 self-questionnaire is an additional measure of the symptoms and side effects experienced by lung cancer patients who receive non-surgical treatment.
Time Frame
Baseline, 3 months, 6 months
Title
Investigate the fatigue change
Description
Fatigue will be assessed by the EORTC-QLQ module measuring cancer-related fatigue (EORTC QLQ-FA12). This self-questionnaire includes 12 items that assess physical, cognitive and emotional fatigue related to cancer. Participants will respond on a Likert scale ranging from "not at all" to "a lot". All scores will be transformed into a scale from 0 to 100, with a higher score indicating a higher degree of fatigue.
Time Frame
Baseline, 3 months, 6 months
Title
Investigate the sleep quality change
Description
The perceived quality of sleep is assessed by the Insomnia Severity Index (ISI) which measures the severity of insomnia. The questionnaire consists of 7 items rated on a 5-point scale ranging from 0 ("none") to 4 ("very severe"). This self-questionnaire makes it possible to evaluate the severity of the patient's sleep difficulties (initial, maintenance, morning insomnia), the degree of sleep dissatisfaction, the level of interference with daily functioning, the degree of appearance of sleep difficulties and the level of anxiety related to insomnia. The total score of the items varies between 0 and 28. A high score indicates greater sleep difficulties.
Time Frame
Baseline, 3 months, 6 months
Title
Investigate the impact of social vulnerability
Description
Social vulnerability will be assessed by the EPICES score (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé). By adding up the points of the 11 binary questions ("Yes"/"No") of the self-questionnaire we obtain the so-called EPICES score. This quantitative score varies from 0 "no precariousness" to 100 "highest precariousness".
Time Frame
Baseline
Title
Investigate the muscle mass and sarcopenia
Description
CT scans
Time Frame
Baseline, 3 months, 6 months
Title
Investigate the immune biomarkers change
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following immune biomarkers will be assay : Natural Killer cells, B lymphocytes, T lymphocytes, monocytes, sub-populations of dendritic cells on frozen PBMC
Time Frame
Baseline and 3 months
Title
Investigate the Activin change (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the TNF-alpha change (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the IL-1béta change (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the IL-6 change (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the Follistatin (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the GDF5 (BMP14) (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the GDF15 (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the IL-10 (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the IL-15 (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the NH3 (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the Aminogramme (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the CRP (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the IFN-gamma change (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the Cortisol change (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the Myostatin change (inflammation biomarkers)
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the Advanced oxidation protein products (AOPP) change
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the Superoxide dismutase (SOD) change
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the catalase (CAT) change
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the malondialdehyde (MDA) change
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).
Time Frame
Baseline and 3 months
Title
Investigate the glutathione peroxidase (GPX) change
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).
Time Frame
Baseline and 3 months
Title
Investigate the Xanthine Myeloperoxidase (MPO) change
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).
Time Frame
Baseline and 3 months
Title
Investigate the Xanthine oxidase (XO) change
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).
Time Frame
Baseline and 3 months
Title
Proportion of patients who have severe toxicity (grade >2)
Description
Occurence of severe toxicity (grade > 2) according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Number of delayed or cancelled treatment sessions and relative dose-intensity (RDI) for patients with grade ≥ 3 chemotherapy-related toxicities, calculated as the ratio of the "delivered" dose-intensity to the "expected" dose-intensity.
Time Frame
Up to 3 months
Title
Progression free survival
Description
Period from the date of randomization to the date of event defined as disease progression or death from any cause
Time Frame
6 months
Title
Acceptability of the study
Description
Ratio of the number of patients included / number of eligible patients
Time Frame
3 months
Title
Tracker activity acceptability
Description
Number of days the activity tracker is worn / number of days in the programme
Time Frame
3 months
Title
Safety of the intervention
Description
Number, type and timing of adverse events due to program
Time Frame
3 months
Title
Adherence of the intervention
Description
number of steps at home realized / number of steps at home prescribed (only in the intervention arm)
Time Frame
3 months and 6 months
Title
Investigate the Physical Activity level change
Description
Daily number of step prescription (only in the intervention arm)
Time Frame
Baseline, 3 months and 6 months
Title
Investigate the glucose change
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the insulin change
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the lactat change
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the PCR change
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months
Title
Investigate the HIF-1 change
Description
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 80 years old, Having a newly metastatic non-small-cell lung cancer (NSCLC) without an EGFR/ALK alteration diagnosis, Being scheduled to receive a 1st line intravenous chemotherapy (Cisplatin and Pemetrexed or Carboplatin and Pemetrexed or Taxol and Carboplatin), and immunotherapy (monoclonal anti-PD-1 and anti-PD-L1 antibodies : Pembrolizumab) treatment NB : patients who have previously received one or more treatments other than chemotherapy (e.g. targeted therapy) and must start their first chemotherapy are eligible, Treated in Centre Leon Berard, Having an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2, Being voluntary and available to get involved throughout the study duration, Being able to engage in Physical Activity with a medical certificate attested by one of the investigators clinical oncologist or the referring oncologist, Affiliated with a social security scheme, Having dated and signed an informed consent. Able to read, write and understand French Exclusion Criteria: Patient with unstable bone metastases or unconsolidated pathologic fractures, Having a central nervous system impairment with neurological disorder avoids the physical exercise practice on a cycle ergometry, Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or cancer in complete remission for more than 5 years), Having severe undernutrition defined according to the Haute Autorité de Santé (i.e. , for an adult aged ≥18 years and < 70 : BIM ≤ 17 or weight loss ≥ 10% in 1 month or ≥15% in 6 months or ≥ 15% compared to the usual weight before the disease diagnosis or albuminemia < 30 g/l ; for an adult aged ≥70 years : BIM < 18 or weight loss ≥ 10% in 1 month or ≥15% in 6 months or an albuminemia < 30 g/l), Having a severe amenia (hemoglobin ≤ 8 g/dl) during the 30 last days prior inclusion, Presenting cardiovascular history or any cardiovascular risk: chronic coronary (or poorly balanced), artery disease, cardiac arrhythmia, symptomatic heart disease, uncontrolled or untreated hypertension, heart attack diagnosed within the last 6 months, coronary angioplasty with or without stent less than 6 months old, coronary artery bypass surgery less than 12 months old, history of poorly balanced type 2 diabetes, In case of diabetes: Glycated hemoglobin (HbA1c) > 7% (in the last 3 months), Stage IV Chronic Obstructive Pulmonary Disease (FEV1 < 30%), Patient with a contraindication to the proposed physical exercise in the study (orthopedic disorder likely to impede walking and pedaling such as disabling coxarthrosis or gonarthrosis, operated or not), Already included in a PA study, Cannot be followed for medical, social, family, geographical or psychological reasons, for the duration of the intervention (3 months) and then for the duration of the post-intervention follow-up (3 months), Patient under legal protection measure (under guardianship, curatorship, safeguard of justice), Deprived of liberty by judicial or administrative decision, Pregnant patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manon Gouez
Phone
+33478782897
Email
manon.gouez@lyon.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Pérol
Phone
+334478782897
Ext
0478782897
Email
olivia.perol@lyon.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice Pérol, MD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manon Gouez
Email
manon.gouez@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Maurice Pérol, MD
First Name & Middle Initial & Last Name & Degree
Benedict Mastroianni, MD
First Name & Middle Initial & Last Name & Degree
Aurélie Swalduz, MD
First Name & Middle Initial & Last Name & Degree
Maxime Boussageon, MD
First Name & Middle Initial & Last Name & Degree
Pierre Saintigny, MD
First Name & Middle Initial & Last Name & Degree
Virginie Avrillon, MD
First Name & Middle Initial & Last Name & Degree
Jérôme Fayette, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35393316
Citation
Gouez M, Perol O, Perol M, Caux C, Menetrier-Caux C, Villard M, Walzer T, Delrieu L, Saintigny P, Marijnen P, Pialoux V, Fervers B. Effect of acute aerobic exercise before immunotherapy and chemotherapy infusion in patients with metastatic non-small-cell lung cancer: protocol for the ERICA feasibility trial. BMJ Open. 2022 Apr 7;12(4):e056819. doi: 10.1136/bmjopen-2021-056819.
Results Reference
derived

Learn more about this trial

Feasibility of an Acute Physical Exercise Before Treatment Infusion for Metastatic Lung Cancer Patients

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