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.
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
Specific diet and/or any lipid-lowering treatment within 15 days prior to randomisation.
Metformin treatment within 15 days prior to randomisation.
Presence of symptomatic cerebral metastasis(es).
Prognosis estimated at less than 3 months.
Parallel
Lipidomic analyses
Biological/Vaccine3 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
Other intervention8-week adapted physical activity program. This program will be adapted to each group
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.
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.
Evaluating and comparing adverse events linked to adapted physical activity
Safety will be assessed in the 3 physical activity groups according to NCI-CTCAE version 5.1
Evaluate and compare changes in patients' quality of life
Quality of life will be assessed in the 3 physical activity groups by the quality of life questionnaire (FACT-C) at inclusion, at 4 weeks and at the end of 8 weeks of physical activity follow-up. This questionnaire is numbered from 0 to 4 (0 is the best case / 4 is the worst case). This questionnaire informe on the physical well-being, familial well-being, emotional well-being, functional well-being.
Prospective collection of biological plasma samples
All samples are kept in order to analyze the expression of a marker of interest in a subpopulation of immune cells not included in the study panels a posteriori.
Progression-free survival
Disease response will be described at each evaluation.
Click on the lead sponsor to view all of their trials.
Centre Georges Francois Leclerc
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
