Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 4 - Healthy volunteers
For this group:
- Volunteers inclusion
- 3 blood samples for lipidomic analysis
- Functional physical assessment
- Completion of questionnaire : previous physical activity
干预措施: Lipidomic analyses (Biological)
Group1 - 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
干预措施: Lipidomic analyses (Biological)
Group1 - 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
干预措施: Adapted physical activity program (Other)
Group 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
干预措施: Lipidomic analyses (Biological)
Group 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
干预措施: Adapted physical activity program (Other)
Group 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
干预措施: Lipidomic analyses (Biological)
Group 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
干预措施: Adapted physical activity program (Other)
Group 4 - Healthy volunteers
For this group:
- Volunteers inclusion
- 3 blood samples for lipidomic analysis
- Functional physical assessment
- Completion of questionnaire : previous physical activity
干预措施: Adapted physical activity program (Other)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- Evaluating and comparing adverse events linked to adapted physical activity(24 months)
- Progression-free survival(24 months)
- Overall survival(24 months)
- Evaluate and compare changes in patients' quality of life(During 8 weeks)
- Prospective collection of biological plasma samples(During 8 weeks)