NCT06944548

Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Centre Georges Francois Leclerc · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Metastatic Colorectal Cancer (CRC)
• Volunteer Subjects

Interventions

Type	Name	Description
BIOLOGICAL	Lipidomic analyses	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
OTHER	Adapted physical activity program	8-week adapted physical activity program. This program will be adapted to each group

Timeline

• Start date: 2025-06-01
• Primary completion: 2030-06-01
• Completion: 2030-06-01
• First posted: 2025-04-25
• Last updated: 2025-04-30

Locations

2 sites across 1 country: France