Status:
NOT_YET_RECRUITING
Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer
Lead Sponsor:
Centre Georges Francois Leclerc
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Metastatic Colorectal Cancer (CRC)
Volunteer Subjects
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06944548
Start Date
June 1 2025
End Date
June 1 2030
Last Update
April 30 2025
Active Locations (2)
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1
Centre Georges-François Leclerc
Dijon, France, 21000
2
CHU Dijon (clinical investigation centre)
Dijon, France, 21000