Metastatic Colorectal Cancer (CRC)Phase 2APACOLNCT06944548
Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer
A Phase 2 study testing Lipidomic analyses and Adapted physical activity program in people with Metastatic Colorectal Cancer (CRC) and Volunteer Subjects, run by Centre Georges Francois Leclerc at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metastatic Colorectal Cancer (CRC), Volunteer Subjects
- What is being tested?
- Lipidomic analyses and Adapted physical activity program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2025to 1 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Centre Georges-François Leclerc
Dijon, 21000
DrJulie VINCENT, 0380737500 ext. +33, jvincent@cgfl.fr
CHU Dijon (clinical investigation centre)
Dijon, 21000
Dr Maxime LUU, 0380295753 ext. +33, maxime.luu@chu-dijon.fr
About this study
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.
Read the 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.
- Being tested
- Lipidomic analyses, Adapted physical activity program
- Keywords
- No special diet, ECOG 0 or 1, Blood albumin ≥30g/L, Age ≥ 18 years, Patients eligible for chemotherapy treatment
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipidomic analysesBiological
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
Adapted physical activity programOther
8-week adapted physical activity program. This program will be adapted to each group
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: Lipidomic analyses; Other: Adapted physical activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For 8 weeks
Secondary outcomes (5)
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
Measured: 24 months
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.
Measured: During 8 weeks
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.
Measured: During 8 weeks
Progression-free survival
Disease response will be described at each evaluation.
Measured: 24 months
Overall survival
Overall survival will be defined as the time elapsed between inclusion and death from any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Julie VINCENT, Principal investigator, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944548
- Sponsor's protocol ID
- 2025-A00415-44
- Acronym
- APACOL
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer
- ClinicalTrials.gov ID
- NCT06944548
- Acronym / sponsor ID
- APACOL / 2025-A00415-44
- Keywords
- No special diet, ECOG 0 or 1, Blood albumin ≥30g/L, Age ≥ 18 years, Patients eligible for chemotherapy treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 - Arms without teacher intervention for adapted physical activity | Active comparator | Biological: Lipidomic analyses, Other: Adapted physical activity programFor 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 |
| Group 2 - Arm " intervention by an adapted physical activity teacher - minimum volume of INCa recomm | Active comparator | Biological: Lipidomic analyses, Other: Adapted physical activity programFor 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 |
| Group 3 - Arm " intervention by an adapted physical activity teacher - maximum volume of INCa recomm | Active comparator | Biological: Lipidomic analyses, Other: Adapted physical activity programFor 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 |
| Group 4 - Healthy volunteers | Active comparator | Biological: Lipidomic analyses, Other: Adapted physical activity programFor this group: * Volunteers inclusion * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of questionnaire : previous physical activity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipidomic analyses3 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 | Biological | 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 program8-week adapted physical activity program. This program will be adapted to each group | Other | 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 |
Primary outcome
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
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.
5 secondary outcomes
Evaluating and comparing adverse events linked to adapted physical activity
Time frame: 24 months
Evaluate and compare changes in patients' quality of life
Time frame: During 8 weeks
Prospective collection of biological plasma samples
Time frame: During 8 weeks
Progression-free survival
Time frame: 24 months
Overall survival
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Julie VINCENT principal investigator
Centre Georges François Leclerc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lipidomic analyses and Adapted physical activity program in people with Metastatic Colorectal Cancer (CRC) and Volunteer Subjects, run by Centre Georges Francois Leclerc at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Laure REROLE (0345348846 ext. +33, arerole@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: For 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.