Clinical trial NCT06944548: Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer
Official title: Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer (CRC)
Volunteer Subjects
Keywords: No special diet
ECOG 0 or 1
Blood albumin ≥30g/L
Age ≥ 18 years
Patients eligible for chemotherapy treatment
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2025-04-25
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 patients only) : No adapted physical activity teacher arm
* Groupe 2 (for patients only) : Arm intervention with an adapted physical activity teacher - minimum volume of INCa recommendations for adapted physical activity
* Groupe 3 (for patients only) : Arm intervention with an adapted physical activity teacher - maximum volume of INCa recommendations for adapted physical activity
* Groupe 4 (for volunteers only) Each participant in the 4 groups will have to complete questionnaires (quality of life, physical activity and dietary intake) and take 3 blood samples for lipidomic analysis.

For patients in groups 1 to 3, participants will be asked to complete a diary to record their daily physical activity and the duration of that activity.

For groups 2 and 3, in addition to the diary, sessions with adapted physical activity teaching will be organised throughout the study.

Eligibility criteria: 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 outcomes:
measure: 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.
timeFrame: For 8 weeks
Secondary outcomes:
measure: Evaluating and comparing adverse events linked to adapted physical activity
timeFrame: 24 months
measure: Evaluate and compare changes in patients' quality of life
timeFrame: During 8 weeks
measure: Prospective collection of biological plasma samples
timeFrame: During 8 weeks
measure: Progression-free survival
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Dijon
country: France
facility: CHU Dijon (clinical investigation centre)
Study officials:
affiliation: Centre Georges François Leclerc
name: Dr Julie VINCENT
role: PRINCIPAL_INVESTIGATOR
References: