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

NCT06944548 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-A00415-44
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  For 8 weeks

Secondary Outcomes (5)

• Evaluating and comparing adverse events linked to adapted physical activity

  24 months

• Evaluate and compare changes in patients' quality of life

  During 8 weeks

• Prospective collection of biological plasma samples

  During 8 weeks

• Progression-free survival

  24 months

• Overall survival

  24 months

Study Arms (4)

Group1 - Arms without teacher intervention for adapted physical activity

ACTIVE COMPARATOR

For this group: * Patient inclusion * No adapted physical activity programme set up and no follow-up by an adapted physical activity teacher * Collection of daily adapted physical activity via a paper diary for 8 weeks. * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of various questionnaires: quality of life, previous physical activity and dietary intake

Biological: Lipidomic analyses; Other: Adapted physical activity program

Group 2 - Arm " intervention by an adapted physical activity teacher - minimum volume of INCa recomm

ACTIVE COMPARATOR

For this group: * Patient inclusion * Implementation of an adapted physical activity programme supervised by a teacher offering 180 minutes of adapted physical activity per week for 8 weeks. Minimum volume recommended by INCa. * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of various questionnaires: quality of life, previous physical activity and dietary intake

Biological: Lipidomic analyses; Other: Adapted physical activity program

Group 3 - Arm " intervention by an adapted physical activity teacher - maximum volume of INCa recomm

ACTIVE COMPARATOR

For this group: * Patient inclusion * Implementation of an adapted physical activity programme supervised by a teacher offering 300 minutes of adapted physical activity per week for 8 weeks. Maximum volume per week recommended by INCa. * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of various questionnaires: quality of life, previous physical activity and dietary intake

Biological: Lipidomic analyses; Other: Adapted physical activity program

Group 4 - Healthy volunteers

ACTIVE COMPARATOR

For this group: * Volunteers inclusion * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of questionnaire : previous physical activity

Biological: Lipidomic analyses; Other: Adapted physical activity program

Interventions

Lipidomic analyses BIOLOGICAL

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

Group 2 - Arm " intervention by an adapted physical activity teacher - minimum volume of INCa recomm; Group 3 - Arm " intervention by an adapted physical activity teacher - maximum volume of INCa recomm; Group 4 - Healthy volunteers; Group1 - Arms without teacher intervention for adapted physical activity

Adapted physical activity program OTHER

8-week adapted physical activity program. This program will be adapted to each group

Group 2 - Arm " intervention by an adapted physical activity teacher - minimum volume of INCa recomm; Group 3 - Arm " intervention by an adapted physical activity teacher - maximum volume of INCa recomm; Group 4 - Healthy volunteers; Group1 - Arms without teacher intervention for adapted physical activity

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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:
• 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).
• The patient does not have internet access / a smartphone / does not wish to download the AXOMOVE application required to take part in the study.
• Patients with a history of cancer other than basal cell cancer, or who have already received systemic anti-cancer treatment.
• 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).

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

Centre Georges-François Leclerc

Dijon, 21000, France

Location

CHU Dijon (clinical investigation centre)

Dijon, 21000, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Dr Julie VINCENT

  Centre Georges François Leclerc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Laure REROLE

CONTACT

0345348846; arerole@cgfl.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)