Back to resultsProspective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology (DParcoursDig)
Primary Purpose
Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma), Colorectal With Associated Risk Factors
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
multidisciplinary assessment and intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma) focused on measuring advanced gastrointestinal (GI) cancers
Eligibility Criteria
Inclusion Criteria:
- Signed and dated informed consent,
- Age ≥ 18 years (no superior limit),
- Histologically confirmed (1) non-colorectal cancer (esophagus, stomach, liver/bile ducts, pancreas, neuroendocrine carcinoma) or (2) colorectal with associated risk factors i.e. ECOG PS 2 (defining significant limitation in daily activities), and/or weight loss ≥ 5% in 1 month or ≥ 10% in 6 months (defining malnutrition/HAS 2019),
- Advanced disease not amenable to surgery, radiation, or combined modality therapy with curative intent (previous resection of primary tumor allowed), treated with first-line chemotherapy for advanced disease (previous [neo]adjuvant chemo[radio]therapy allowed); or resectable/potentially resectable disease receiving a triplet chemotherapy regimen in a peri-operative setting (e.g. FOLFIRINOX, FLOT) (moderate risk at frailty score)
- Patients able to attend for administration of chemotherapy,
- Life expectancy ≥ 3 months,
- Registration in a National Health Care System (Couverture Maladie Universelle [CMU] included).
Exclusion Criteria:
- Other active non gastro-intestinal cancers
- Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,
- Pregnancy or breastfeeding,
- Protected adults (individuals under guardianship by court order).
Note: participation to another concomitant clinical trial is allowed, but the patient must inform the Investigator and get an authorization from the Sponsor.
Sites / Locations
- Institut Curie
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with advanced gastrointestinal (GI) cancers
Arm Description
All patients will receive usual care including: Chemotherapy at the investigator's choice, Outpatient clinical visits according to the regular schedule, Tumor evaluation based on tumor marker serum levels, as appropriate, and TAP-CT with intravenous contrast injection every 8 weeks. Nutritional support will consist of: A nutrition assessment by a dieticianat W4 and W8 (plus additional visits if required), Nutritional intervention ± oral supplementation, enteral tube feeding, and/or parenteral nutrition). Physical activity support will consist of: A physical condition assessment by a APA profesional including physical tests (6-minute walking test, handgrip test, chair stand fitness test, get-up and go test, balance in single-leg and bipodal stance) at baseline, W4 and W8, Personalized counselling for unsupervised home-based exercises
Outcomes
Primary Outcome Measures
Program faisability
Program feasibility will be satisfactory if ≥ 80% of patients with advanced GI cancers included in the program complete the baseline, W4 and W8 assessments
Secondary Outcome Measures
Dimensions of EORTC QLQ-C30
EORTC QLQ-C30 completion
Fatigue measured by Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) completion, a score form 0 to 10 will be given
Pain measured by VAS and analgesics consumption
VAS completion and analgesics consumption report, a score form 0 to 10 will be given and report of analgesics consumption will be given by name and dose
Nutritional status/inflammation measure
weight in kilograms, body mass index will be reported in BMI in kg/m^2, food intakes
Physical condition assessed
International Physical Activity Questionnaire (IPAQ),
Geriatric assessment if age ≥ 70
G8 score from 0 to 17
Chemotherapy tolerance assessed
toxicities (using Common Terminology Criteria for Adverse Events [CTCAE v5.0])
Progression Free Survival and Overall Survival
Progression Free Survival and Overall Survival
Patient's satisfaction measured by VAS
VAS completion with a score from 0 to 10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04478175
Brief Title
Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology
Acronym
DParcoursDig
Official Title
Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology - DISSPO Parcours Dig' Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
October 5, 2022 (Actual)
Study Completion Date
October 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
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
Patients with advanced gastrointestinal (GI) cancers are very often sarcopenic/malnourished at diagnosis (> 60% of cases) and at high risk of rapid clinical deterioration. These patients have important supportive care needs that represent a major challenge for improving treatment tolerance and patient survival and health-related quality of life (HRQoL).
Malnutrition and sarcopenia (muscle wasting and dysfunction) are associated with an increased risk of death, complications from chemotherapy, infections, emergency procedures and hospitalizations, and increased costs of care. Therefore, malnutrition and sarcopenia represent a major clinical target in GI cancers.
Interventions targeting malnutrition/sarcopenia should be implemented as early as possible in patients' pathways, these syndromes being reversible at early stages but not at late stages.
A multidisciplinary assessment at diagnosis and therapeutic approach combining nutritional support and and adapted physical activity (APA) in addition to anticancer treatments should be systematically implemented in patients with advanced GI cancers.
This type of intervention complies with the standards recommended by the National Cancer Institute (INCa) to promote the practice of physical activity during and after treatment in oncology.
Detailed Description
All patients will receive usual care including:
Chemotherapy at the investigator's choice,
Outpatient clinical visits according to the regular schedule,
Tumor evaluation based on tumor marker serum levels, as appropriate, and TAP-CT with intravenous contrast injection every 8 weeks.
Nutritional support will consist of:
A nutrition assessment by a dietician including a VAS of food intakes at baseline, at W4 and W8 (plus additional visits if required),
Nutritional intervention according to the Société Francophone de Nutrition Clinique et Métabolisme (SFNEP) guidelines (dietetic counseling for all patients ± oral supplementation, enteral tube feeding, and/or parenteral nutrition).
Physical activity support will consist of physical condition assessed by International Physical Activity Questionnaire (IPAQ), performance status (ECOG PS), resting heart rate and blood pressure, 6-minute walking test (speed, fatigue), handgrip test, chair stand fitness test, get-up and go test, balance in single-leg and bipodal stance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma), Colorectal With Associated Risk Factors
Keywords
advanced gastrointestinal (GI) cancers
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
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with advanced gastrointestinal (GI) cancers
Arm Type
Other
Arm Description
All patients will receive usual care including:
Chemotherapy at the investigator's choice,
Outpatient clinical visits according to the regular schedule,
Tumor evaluation based on tumor marker serum levels, as appropriate, and TAP-CT with intravenous contrast injection every 8 weeks.
Nutritional support will consist of:
A nutrition assessment by a dieticianat W4 and W8 (plus additional visits if required),
Nutritional intervention ± oral supplementation, enteral tube feeding, and/or parenteral nutrition).
Physical activity support will consist of:
A physical condition assessment by a APA profesional including physical tests (6-minute walking test, handgrip test, chair stand fitness test, get-up and go test, balance in single-leg and bipodal stance) at baseline, W4 and W8,
Personalized counselling for unsupervised home-based exercises
Intervention Type
Other
Intervention Name(s)
multidisciplinary assessment and intervention
Intervention Description
early multidisciplinary assessment and intervention in addition to usual patient care
Primary Outcome Measure Information:
Title
Program faisability
Description
Program feasibility will be satisfactory if ≥ 80% of patients with advanced GI cancers included in the program complete the baseline, W4 and W8 assessments
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Dimensions of EORTC QLQ-C30
Description
EORTC QLQ-C30 completion
Time Frame
12 months
Title
Fatigue measured by Visual Analogue Scale (VAS)
Description
Visual Analogue Scale (VAS) completion, a score form 0 to 10 will be given
Time Frame
12 months
Title
Pain measured by VAS and analgesics consumption
Description
VAS completion and analgesics consumption report, a score form 0 to 10 will be given and report of analgesics consumption will be given by name and dose
Time Frame
12 months
Title
Nutritional status/inflammation measure
Description
weight in kilograms, body mass index will be reported in BMI in kg/m^2, food intakes
Time Frame
12 months
Title
Physical condition assessed
Description
International Physical Activity Questionnaire (IPAQ),
Time Frame
12 months
Title
Geriatric assessment if age ≥ 70
Description
G8 score from 0 to 17
Time Frame
12 months
Title
Chemotherapy tolerance assessed
Description
toxicities (using Common Terminology Criteria for Adverse Events [CTCAE v5.0])
Time Frame
12 months
Title
Progression Free Survival and Overall Survival
Description
Progression Free Survival and Overall Survival
Time Frame
12 months
Title
Patient's satisfaction measured by VAS
Description
VAS completion with a score from 0 to 10
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed and dated informed consent,
Age ≥ 18 years (no superior limit),
Histologically confirmed (1) non-colorectal cancer (esophagus, stomach, liver/bile ducts, pancreas, neuroendocrine carcinoma) or (2) colorectal with associated risk factors i.e. ECOG PS 2 (defining significant limitation in daily activities), and/or weight loss ≥ 5% in 1 month or ≥ 10% in 6 months (defining malnutrition/HAS 2019),
Advanced disease not amenable to surgery, radiation, or combined modality therapy with curative intent (previous resection of primary tumor allowed), treated with first-line chemotherapy for advanced disease (previous [neo]adjuvant chemo[radio]therapy allowed); or resectable/potentially resectable disease receiving a triplet chemotherapy regimen in a peri-operative setting (e.g. FOLFIRINOX, FLOT) (moderate risk at frailty score)
Patients able to attend for administration of chemotherapy,
Life expectancy ≥ 3 months,
Registration in a National Health Care System (Couverture Maladie Universelle [CMU] included).
Exclusion Criteria:
Other active non gastro-intestinal cancers
Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,
Pregnancy or breastfeeding,
Protected adults (individuals under guardianship by court order).
Note: participation to another concomitant clinical trial is allowed, but the patient must inform the Investigator and get an authorization from the Sponsor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique GILLON
Organizational Affiliation
Institut Curie
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
12. IPD Sharing Statement
Learn more about this trial
Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology
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