NCT06944548Not yet recruitingPhase 2
Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer
Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 10 Apr 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 1 Jun 2030
- Lead sponsor
- Centre Georges Francois Leclerc
- Diseases
- Colorectal cancer
- NCT number
- NCT06944548
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 54
- From 1 Jun 2025 to the primary completion date, 1 Jun 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Persons with a special diet, metformin treatment and/or any lipid-lowering treatment in the 15 days prior to inclusion.
Other illness
- Patients with a history of cancer other than basal cell cancer, or who have already received systemic anti-cancer treatment.
Other
- \- 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)).
- 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.
- 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).
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU Dijon (clinical investigation centre) Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.