Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer
- Conditions
- Metastatic Colorectal Cancer (CRC)Volunteer Subjects
- Interventions
- Biological: Lipidomic analysesOther: Adapted physical activity program
- Registration Number
- NCT06944548
- Lead Sponsor
- Centre Georges Francois Leclerc
- Brief Summary
APACOL is a pilot, bicentric, randomised, open-label, prospective, category 2 study. The presence of colon cancer modifies blood lipid parameters which are likely to have an impact on the efficacy of anti-cancer treatments. Previous data support the hypothesis that appropriate physical activity could modify the blood lipid parameters involved in chemoresistance in patients with metastatic colorectal cancer.
The aim of the APACOL study is to investigate the impact of modulating the frequency (volume per week) of physical activity recommended by INCa on the variation in lipid parameters involved in chemoresistance in patients with metastatic colon cancer, with a reference level of these lipid parameters in people without cancer provided by the participation of volunteers who are not ill.
The expectations at the end of this study are an improvement in the patient's quality of life / an improvement in the tolerance and efficacy of the chemotherapy treatment / identification of the frequency of APAs needed to vary the lipid metabolism involved in chemoresistance.
- Detailed Description
This study will be open on 2 sites (CIC CHU Dijon with inclusion of 18 volunteers and CGFL with inclusion of 36 patients).
The participants will be randomized in 4 differents groups :
* Group 1 (for patients only) : No adapted physical activity teacher arm
* Groupe 2 (for patients only) : Arm intervention with an adapted physical activity teacher - minimum volume of INCa recommendations for adapted physical activity
* Groupe 3 (for patients only) : Arm intervention with an adapted physical activity teacher - maximum volume of INCa recommendations for adapted physical activity
* Groupe 4 (for volunteers only) Each participant in the 4 groups will have to complete questionnaires (quality of life, physical activity and dietary intake) and take 3 blood samples for lipidomic analysis.
For patients in groups 1 to 3, participants will be asked to complete a diary to record their daily physical activity and the duration of that activity.
For groups 2 and 3, in addition to the diary, sessions with adapted physical activity teaching will be organised throughout the study.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group1 - Arms without teacher intervention for adapted physical activity Lipidomic analyses For this group: * Patient inclusion * No adapted physical activity programme set up and no follow-up by an adapted physical activity teacher * Collection of daily adapted physical activity via a paper diary for 8 weeks. * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of various questionnaires: quality of life, previous physical activity and dietary intake Group1 - Arms without teacher intervention for adapted physical activity Adapted physical activity program For this group: * Patient inclusion * No adapted physical activity programme set up and no follow-up by an adapted physical activity teacher * Collection of daily adapted physical activity via a paper diary for 8 weeks. * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of various questionnaires: quality of life, previous physical activity and dietary intake Group 2 - Arm " intervention by an adapted physical activity teacher - minimum volume of INCa recomm Lipidomic analyses For this group: * Patient inclusion * Implementation of an adapted physical activity programme supervised by a teacher offering 180 minutes of adapted physical activity per week for 8 weeks. Minimum volume recommended by INCa. * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of various questionnaires: quality of life, previous physical activity and dietary intake Group 2 - Arm " intervention by an adapted physical activity teacher - minimum volume of INCa recomm Adapted physical activity program For this group: * Patient inclusion * Implementation of an adapted physical activity programme supervised by a teacher offering 180 minutes of adapted physical activity per week for 8 weeks. Minimum volume recommended by INCa. * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of various questionnaires: quality of life, previous physical activity and dietary intake Group 3 - Arm " intervention by an adapted physical activity teacher - maximum volume of INCa recomm Lipidomic analyses For this group: * Patient inclusion * Implementation of an adapted physical activity programme supervised by a teacher offering 300 minutes of adapted physical activity per week for 8 weeks. Maximum volume per week recommended by INCa. * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of various questionnaires: quality of life, previous physical activity and dietary intake Group 3 - Arm " intervention by an adapted physical activity teacher - maximum volume of INCa recomm Adapted physical activity program For this group: * Patient inclusion * Implementation of an adapted physical activity programme supervised by a teacher offering 300 minutes of adapted physical activity per week for 8 weeks. Maximum volume per week recommended by INCa. * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of various questionnaires: quality of life, previous physical activity and dietary intake Group 4 - Healthy volunteers Lipidomic analyses For this group: * Volunteers inclusion * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of questionnaire : previous physical activity Group 4 - Healthy volunteers Adapted physical activity program For this group: * Volunteers inclusion * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of questionnaire : previous physical activity
- Primary Outcome Measures
Name Time Method To determine the impact of adapted physical activity on the concentration of complex lipids in a population of patients with metastatic colorectal cancer treated with chemotherapy. For 8 weeks The concentrations of complex lipids will be measured by high-performance liquid chromatography-mass spectrometry and by gas chromatography-mass spectrometry.
The different concentrations of complex lipids will be compared between the 3 groups of patients (groups 1, 2 and 3) benefiting from a different frequency of adapted physical activity sessions.
- Secondary Outcome Measures
Name Time Method Evaluating and comparing adverse events linked to adapted physical activity 24 months Safety will be assessed in the 3 physical activity groups according to NCI-CTCAE version 5.1
Progression-free survival 24 months Disease response will be described at each evaluation.
Overall survival 24 months Overall survival will be defined as the time elapsed between inclusion and death from any cause.
Evaluate and compare changes in patients' quality of life During 8 weeks Quality of life will be assessed in the 3 physical activity groups by the quality of life questionnaire (FACT-C) at inclusion, at 4 weeks and at the end of 8 weeks of physical activity follow-up. This questionnaire is numbered from 0 to 4 (0 is the best case / 4 is the worst case).
This questionnaire informe on the physical well-being, familial well-being, emotional well-being, functional well-being.Prospective collection of biological plasma samples During 8 weeks All samples are kept in order to analyze the expression of a marker of interest in a subpopulation of immune cells not included in the study panels a posteriori.
Trial Locations
- Locations (2)
CHU Dijon (clinical investigation centre)
🇫🇷Dijon, France
Centre Georges-François Leclerc
🇫🇷Dijon, France