Clinical Trial Radar

Name: Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer
Creator: Centre Georges Francois Leclerc
Published: 2025-04-25
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT06944548 (APACOL) for Metastatic Colorectal Cancer (CRC), Volunteer Subjects is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer (APACOL) Phase 2 54 Open-Label

Not yet recruiting

Clinical Trial NCT06944548 (APACOL) is designed to study Prevention for Metastatic Colorectal Cancer (CRC), Volunteer Subjects. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 June 2025 until the study accrues 54 participants. Led by Centre Georges Francois Leclerc, this study is expected to complete by 1 June 2030. The latest data from ClinicalTrials.gov was last updated on 30 April 2025.

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 ...

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 activit...

Official Title

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

Conditions

Metastatic Colorectal Cancer (CRC)Volunteer Subjects

Other Study IDs

APACOL
2025-A00415-44

NCT ID Number

NCT06944548

Start Date (Actual)

2025-06-01

Last Update Posted

2025-04-30

Completion Date (Estimated)

2030-06-01

Enrollment (Estimated)

Study Type

Interventional

PHASE

Phase 2

Status

Not yet recruiting

Keywords

No special diet
ECOG 0 or 1
Blood albumin ≥30g/L
Age ≥ 18 years
Patients eligible for chemotherapy treatment

Primary Purpose

Prevention

Design Allocation

Randomized

Interventional Model

Parallel

Masking

None (Open Label)

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
Active ComparatorGroup1 - Arms without teacher intervention for adapted physical activity 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	Lipidomic analyses 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 program 8-week adapted physical activity program. This program will be adapted to each group
Active ComparatorGroup 2 - Arm " intervention by an adapted physical activity teacher - minimum volume of INCa recomm 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	Lipidomic analyses 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 program 8-week adapted physical activity program. This program will be adapted to each group
Active ComparatorGroup 3 - Arm " intervention by an adapted physical activity teacher - maximum volume of INCa recomm 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	Lipidomic analyses 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 program 8-week adapted physical activity program. This program will be adapted to each group
Active ComparatorGroup 4 - Healthy volunteers For this group: * Volunteers inclusion * 3 blood samples for lipidomic analysis * Functional physical assessment * Completion of questionnaire : previous physical activity	Lipidomic analyses 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 program 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.	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	Safety will be assessed in the 3 physical activity groups according to NCI-CTCAE version 5.1	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.	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.	During 8 weeks
Progression-free survival	Disease response will be described at each evaluation.	24 months
Overall survival	Overall survival will be defined as the time elapsed between inclusion and death from any cause.	24 months

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

Accepts Healthy Volunteers

Yes

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.

- 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).

Centre Georges Francois Leclerc

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

Study Central Contact

Contact: Anne-Laure REROLE, 0345348846, [email protected]

2 Study Locations in 1 Countries

France

Centre Georges-François Leclerc, Dijon, 21000, France

DrJulie VINCENT, Contact, 0380737500, [email protected]

CHU Dijon (clinical investigation centre), Dijon, 21000, France

Dr Maxime LUU, Contact, 0380295753, [email protected]