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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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Centre Georges-François Leclerc
Dijon, France
CHU Dijon (clinical investigation centre)
Dijon, France
Start Date
June 1, 2025
Primary Completion Date
June 1, 2030
Completion Date
June 1, 2030
Last Updated
April 30, 2025
54
ESTIMATED participants
Lipidomic analyses
BIOLOGICAL
Adapted physical activity program
OTHER
Lead Sponsor
Centre Georges Francois Leclerc
Collaborators
Data Source & Attribution
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