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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre Georges Francois Leclerc

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Lipidomic analyses
  • Adapted physical activity program

Treatment groups

54 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Centre Georges Francois Leclerc

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator