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

Launched by CENTRE GEORGES FRANCOIS LECLERC · Apr 17, 2025

Keywords

ClinConnect Summary

The APACOL study is looking at how adapted physical activity might help patients with metastatic colorectal cancer (a type of cancer that has spread from the colon to other parts of the body) during their chemotherapy treatment. Researchers believe that exercise could change the levels of certain fats in the blood, which might improve how well the chemotherapy works and enhance the quality of life for patients. To find out how much physical activity is beneficial, the study will compare patients with metastatic colorectal cancer to healthy volunteers who do not have cancer.

To participate in this trial, patients need to be at least 18 years old, have a confirmed diagnosis of metastatic colorectal cancer, and be able to engage in chemotherapy treatment. They should also be in good enough health to take part in physical activities and attend regular study visits. Healthy volunteers need to be between 18 and 80 years old and generally healthy. Participants can expect to undergo monitoring, including physical activities and blood tests, while learning more about the role of exercise in their treatment. This study is not yet recruiting, but it aims to provide valuable insights into how physical activity may support cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for patients:
• • Age ≥ 18 years
• • Patient with histologically proven metastatic colorectal cancer
• • Patient eligible for treatment with chemotherapy, in combination or not with other anti-cancer treatments according to standard management
• • Have a performance status of 0 or 1 according to the WHO ECOG index
• • Blood albumin value ≥30g/L
• • Patient able to give consent and able to undergo study monitoring, including visits, physical activities, blood sampling
• • Patient affiliated to a social security scheme or equivalent.
• Inclusion Criteria for healthy volunteers :
• • Age ≥ 18 years ≤ 80 years
• • Persons capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. Written informed consent and any required authorisation must be obtained from the healthy volunteer prior to carrying out any procedure related to the protocol, including examinations to assess the eligibility of the person
• • Persons who are affiliated to or are beneficiaries of a social security scheme according to local requirements.
• Exclusion Criteria for patients :
• • - Independent physical activity exceeding INCa recommendations: Moderate physical activity greater than or equal to 300 minutes/week (≥5h) or intense physical activity greater than or equal to 150 minutes/week (≥2.5h)).
• • Specific diet and/or any lipid-lowering treatment within 15 days prior to randomisation.
• • Metformin treatment within 15 days prior to randomisation.
• * Any medical conditions or co-morbidities likely to contraindicate the practice of physical activity. The list below is not exhaustive:
• • Previous stroke Myocardial infarction in the 6 months prior to inclusion Uncontrolled arterial hypertension Severe cardiovascular or respiratory disease Rheumatological/orthopaedic conditions or bone lesions at risk of fracture
• • Presence of symptomatic cerebral metastasis(es).
• • Prognosis estimated at less than 3 months.
• • Unable to undergo medical monitoring of the trial and the various visits for geographical, social or psychological reasons.
• • Persons deprived of their liberty or under guardianship (including curatorship).
• • Pregnant or breast-feeding women (pregnancy test compulsory at inclusion).
• • The patient does not have internet access / a smartphone / does not wish to download the AXOMOVE application required to take part in the study.
• Exclusion Criteria for healthy volunteers :
• • Patients with a history of cancer other than basal cell cancer, or who have already received systemic anti-cancer treatment.
• • Persons with a special diet, metformin treatment and/or any lipid-lowering treatment in the 15 days prior to inclusion.
• • Persons with moderate physical activity exceeding 300 minutes/week or intense physical activity exceeding 150 minutes/week.
• • Persons deprived of their liberty or under guardianship (including curatorship).
• • Pregnant or breast-feeding women (pregnancy test compulsory at inclusion).