Metastatic Colorectal Cancer (CRC)Volunteer Subjects
Investigational drug(s) / intervention(s)
Lipidomic analysesAdapted physical activity program
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
Adapted physical activity program: 8-week adapted physical activity program. This program will be adapted to each group
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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).
Primary outcome measure(s)
To determine the impact of adapted physical activity on the concentration of complex lipids in a population of patients with metastatic colorectal cancer treated with chemotherapy. — For 8 weeks The concentrations of complex lipids will be measured by high-performance liquid chromatography-mass spectrometry and by gas chromatography-mass spectrometry.
The different concentrations of complex lipids will be compared between the 3 groups of patients (groups 1, 2 and 3) benefiting from a different frequency of adapted physical activity sessions.
Trial sites (2)
Facility
City
Region
Status
Centre Georges-François Leclerc
Dijon
France
CHU Dijon (clinical investigation centre)
Dijon
France
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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