Evolution of the Physical Condition in Treated Cancer Patients (PROTECT-01)
Primary Purpose
Non-small Cell Lung Cancer Metastatic, Breast Cancer Female, Colon Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adaptated Physical Activity
Sponsored by
About this trial
This is an interventional supportive care trial for Non-small Cell Lung Cancer Metastatic
Eligibility Criteria
Inclusion Criteria:
- Woman with breast cancer treated with adjuvant chemotherapy (taxane) or patient with colon cancer treated with adjuvant regimen (FOLFOX) or patient with locally advanced or metastatic lung cancer
- Patient without contraindication to the study-specific assessments
- Eastern Cooperative Oncology Group ≤ 2
- Age ≥ 18 years old
- Life expectancy > 6 months
- Able to speak, read and understand French
- Written informed consent obtained from the patient
- Registration in a national health care system
Exclusion Criteria:
- Patient with psychiatric, neurologic or musculoskeletal disorders
- Pregnant or breastfeeding women
- Minor or protected adult
Sites / Locations
- Centre Paul StraussRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental: observational cohort
Arm Description
Evaluation of the physical condition and the quality of life
Outcomes
Primary Outcome Measures
evolution of exercise tolerance
To describe exercise tolerance, by a six-minute walk test, in patients treated for a cancer (of lung, breast or colon) after 8 weeks of treatment.
Secondary Outcome Measures
measurement of parameters reflecting the physical condition
To describe objective and felt fatigue by Fonctional assessment of chronic illness therapy-fatique (41 items scale)
measurement of parameters reflecting the physical condition
To describe muscular strenght by FPmax: Maximal strenght of finger flexors; (measured in Newton with a dynamometer)
measurement of parameters reflecting the physical condition
To describe muscular strenght by IFP: Fatigability indexof finger flexors; (measured in Newton with a dynamometer)
measurement of parameters reflecting the physical condition
To describe muscular strenght by FIEmax: Maximal isometric strenght of knee extensors; (measured in Newton with a dynamometer)
measurement of parameters reflecting the physical condition
To describe muscular strenght by IFE: Fatigability index of knee extensors; (measured in Newton with a dynamometer)
measurement of the lean body mass condition
To describe lean body mass by impedancemeter
measurement of the pulmonary function
Spirometry measures lung function, specifically the amount (volume) of air that can be inhaled and exhaled
measurement of parameters reflecting the physical condition
To describe anxiety by Hospital Anxiety and Depression scale (14 items)
measurement of parameters reflecting the physical condition
To describe physical activity level by by Global Physical Activity questionnaire
measurement of parameters reflecting the physical condition
To describe physical performance index by Short Physical Performance Battery which is a group of measures that combines the results of the gait speed
measurement of parameters reflecting the physical condition
To describe physical performance index by Short Physical Performance Battery which is a group of measures that combines the results of the chair stand
measurement of parameters reflecting the physical condition
To describe physical performance index by Short Physical Performance Battery which is a group of measures that combines the results of the balance tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03956641
Brief Title
Evolution of the Physical Condition in Treated Cancer Patients
Acronym
PROTECT-01
Official Title
Evolution of the Physical Condition in Treated Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
September 17, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Paul Strauss
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
Adaptated Physical Activity (APA) during treatment of cancer is one of the actual global health recommendation because of the benefits observed in several parameters evaluated in many clinical studies. A best knowledge of the physical and medical characteristics of patients, including type of cancer and type of treatment, is primordial to optimize the patient care and the effectiveness of APA programs.
Descriptive, explorative and prospective study of 3 different populations:
One population with locally advanced or metastatic non-small cell lung cancer treated with multiple therapeutic lines. Two different populations of early cancer patients and treated with a platinum-based regimen for colon cancer and a taxane-based chemotherapy for breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer Metastatic, Breast Cancer Female, Colon Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental: observational cohort
Arm Type
Experimental
Arm Description
Evaluation of the physical condition and the quality of life
Intervention Type
Other
Intervention Name(s)
Adaptated Physical Activity
Intervention Description
Evaluation of the physical condition and the quality of life during the course of treatment (after 8 weeks of treatment) and at the end of the treatment's line (except for breast cancer patients)
Primary Outcome Measure Information:
Title
evolution of exercise tolerance
Description
To describe exercise tolerance, by a six-minute walk test, in patients treated for a cancer (of lung, breast or colon) after 8 weeks of treatment.
Time Frame
change from baseline exercise tolerance at 12 weeks after the end of the treatment
Secondary Outcome Measure Information:
Title
measurement of parameters reflecting the physical condition
Description
To describe objective and felt fatigue by Fonctional assessment of chronic illness therapy-fatique (41 items scale)
Time Frame
change from baseline physical condition at 12 weeks after the end of the treatment
Title
measurement of parameters reflecting the physical condition
Description
To describe muscular strenght by FPmax: Maximal strenght of finger flexors; (measured in Newton with a dynamometer)
Time Frame
change from baseline physical condition at 12 weeks after the end of the treatment
Title
measurement of parameters reflecting the physical condition
Description
To describe muscular strenght by IFP: Fatigability indexof finger flexors; (measured in Newton with a dynamometer)
Time Frame
change from baseline physical condition at 12 weeks after the end of the treatment
Title
measurement of parameters reflecting the physical condition
Description
To describe muscular strenght by FIEmax: Maximal isometric strenght of knee extensors; (measured in Newton with a dynamometer)
Time Frame
change from baseline physical condition at 12 weeks after the end of the treatment
Title
measurement of parameters reflecting the physical condition
Description
To describe muscular strenght by IFE: Fatigability index of knee extensors; (measured in Newton with a dynamometer)
Time Frame
change from baseline physical condition at 12 weeks after the end of the treatment
Title
measurement of the lean body mass condition
Description
To describe lean body mass by impedancemeter
Time Frame
change from baseline physical condition at 12 weeks after the end of the treatment
Title
measurement of the pulmonary function
Description
Spirometry measures lung function, specifically the amount (volume) of air that can be inhaled and exhaled
Time Frame
change from baseline physical condition at 12 weeks after the end of the treatment
Title
measurement of parameters reflecting the physical condition
Description
To describe anxiety by Hospital Anxiety and Depression scale (14 items)
Time Frame
change from baseline physical condition at 12 weeks after the end of the treatment
Title
measurement of parameters reflecting the physical condition
Description
To describe physical activity level by by Global Physical Activity questionnaire
Time Frame
change from baseline physical condition at 12 weeks after the end of the treatment
Title
measurement of parameters reflecting the physical condition
Description
To describe physical performance index by Short Physical Performance Battery which is a group of measures that combines the results of the gait speed
Time Frame
change from baseline physical condition at 12 weeks after the end of the treatment
Title
measurement of parameters reflecting the physical condition
Description
To describe physical performance index by Short Physical Performance Battery which is a group of measures that combines the results of the chair stand
Time Frame
change from baseline physical condition at 12 weeks after the end of the treatment
Title
measurement of parameters reflecting the physical condition
Description
To describe physical performance index by Short Physical Performance Battery which is a group of measures that combines the results of the balance tests
Time Frame
change from baseline physical condition at 12 weeks after the end of the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Woman with breast cancer treated with adjuvant chemotherapy (taxane) or patient with colon cancer treated with adjuvant regimen (FOLFOX) or patient with locally advanced or metastatic lung cancer
Patient without contraindication to the study-specific assessments
Eastern Cooperative Oncology Group ≤ 2
Age ≥ 18 years old
Life expectancy > 6 months
Able to speak, read and understand French
Written informed consent obtained from the patient
Registration in a national health care system
Exclusion Criteria:
Patient with psychiatric, neurologic or musculoskeletal disorders
Pregnant or breastfeeding women
Minor or protected adult
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie SARTORI
Phone
+33 388 25 85 41
Email
vsartori@strasbourg.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Joris MALLARD
Phone
+ 33 388 25 85 68
Email
jmallard@strasbourg.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland SCHOTT, Md
Organizational Affiliation
Centre Paul Strauss
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SARTORI Valérie
Phone
+33 368 76 72 23
Email
v.sartori@icans.eu
12. IPD Sharing Statement
Citations:
PubMed Identifier
32903594
Citation
Mallard J, Hucteau E, Schott R, Petit T, Demarchi M, Belletier C, Ben Abdelghani M, Carinato H, Chiappa P, Fischbach C, Kalish-Weindling M, Bousiniere A, Dufour S, Favret F, Pivot X, Hureau TJ, Pagano AF. Evolution of Physical Status From Diagnosis to the End of First-Line Treatment in Breast, Lung, and Colorectal Cancer Patients: The PROTECT-01 Cohort Study Protocol. Front Oncol. 2020 Aug 7;10:1304. doi: 10.3389/fonc.2020.01304. eCollection 2020.
Results Reference
derived
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Evolution of the Physical Condition in Treated Cancer Patients
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