Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer (APACOL)
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Anne-Laure REROLE
- Phone Number: +33 0345348846
- Email: arerole@cgfl.fr
Study Locations
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Dijon, France, 21000
- Centre Georges-François Leclerc
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Contact:
- DrJulie VINCENT
- Phone Number: +33 0380737500
- Email: jvincent@cgfl.fr
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Dijon, France, 21000
- CHU Dijon (clinical investigation centre)
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Contact:
- Dr Maxime LUU
- Phone Number: +33 0380295753
- Email: maxime.luu@chu-dijon.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group1 - Arms without teacher intervention for adapted physical activity
For this group:
|
3 blood samples taken from 2 x 6 mL EDTA tubes for patients
8-week adapted physical activity program.
This program will be adapted to each group
|
|
Active Comparator: Group 2 - Arm " intervention by an adapted physical activity teacher - minimum volume of INCa recomm
For this group:
|
3 blood samples taken from 2 x 6 mL EDTA tubes for patients
8-week adapted physical activity program.
This program will be adapted to each group
|
|
Active Comparator: Group 3 - Arm " intervention by an adapted physical activity teacher - maximum volume of INCa recomm
For this group:
|
3 blood samples taken from 2 x 6 mL EDTA tubes for patients
8-week adapted physical activity program.
This program will be adapted to each group
|
|
Active Comparator: Group 4 - Healthy volunteers
For this group:
|
3 blood samples taken from 2 x 6 mL EDTA tubes for patients
8-week adapted physical activity program.
This program will be adapted to each group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: For 8 weeks
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluating and comparing adverse events linked to adapted physical activity
Time Frame: 24 months
|
Safety will be assessed in the 3 physical activity groups according to NCI-CTCAE version 5.1
|
24 months
|
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Evaluate and compare changes in patients' quality of life
Time Frame: During 8 weeks
|
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. |
During 8 weeks
|
|
Progression-free survival
Time Frame: 24 months
|
Disease response will be described at each evaluation.
|
24 months
|
|
Overall survival
Time Frame: 24 months
|
Overall survival will be defined as the time elapsed between inclusion and death from any cause.
|
24 months
|
|
Prospective collection of biological plasma samples
Time Frame: During 8 weeks
|
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.
|
During 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr Julie VINCENT, Centre Georges Francois Leclerc
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A00415-44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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