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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
54
3 blood samples taken from 2 x 6 mL EDTA tubes for patients * At baseline * Week 5 of the adapted physical activity protocol * Follow-up visit for adapted physical activity 1 blood sample taken from 2 x 6 mL EDTA tubes for volunteers * At baseline
8-week adapted physical activity program. This program will be adapted to each group
Centre Georges-François Leclerc
Dijon, France
CHU Dijon (clinical investigation centre)
Dijon, France
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.
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.
Time frame: For 8 weeks
Evaluating and comparing adverse events linked to adapted physical activity
Safety will be assessed in the 3 physical activity groups according to NCI-CTCAE version 5.1
Time frame: 24 months
Evaluate and compare changes in patients' quality of life
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.
Time frame: During 8 weeks
Prospective collection of biological plasma samples
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.
Time frame: During 8 weeks
Progression-free survival
Disease response will be described at each evaluation.
Time frame: 24 months
Overall survival
Overall survival will be defined as the time elapsed between inclusion and death from any cause.
Time frame: 24 months
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