Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help in Treatment for Breast Cancer

Study Overview
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Brief Summary
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Integrative approaches to promote wellness and reduce the distress associated with cancer are considered as essential components of cancer care. In case, exercise training has been shown to produce many positive physiological and psychological benefits. Mindfulness-based stress reduction program shows similar beneficial effects, and especially in emotional distress management. The aim of the study is to examine the cumulative effect of an 8 week-exercise-training program combined with an MBSR program on cardio-respiratory fitness and quality of life in women with breast cancer. These effects are thought to be mediated in part through changes in underlying brain processes, that investigators will be put in light. Through telomerase activity, oxidative stress, mitochondrial respiration and blood cytokine level measurements, investigators could expect to better understand the effect of these combined training in breast cancer.

Official Title
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Effect of a Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help to Improve Exercise Capacity and Quality of Life in Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Endurance exercise training
* Other: Mindfulness-based-stress-reduction
* Other: Both interventions together
* Other: Vo2max measurements
* Genetic: Telomerase activity on a blood sample
* Other: Quality of life (questionnaires)
* Other: Cerebral IRMf


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer Having completed the chemotherapy period Undergoing radiotherapy and/or hormono therapy Exclusion Criteria: Regular physical activity higher than 4 hours per week. Any disease cardiac, respiratory, neurological or articular disease, which counteract the muscular training )

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control patients with no intervention<br>group without intervention | Other: Vo2max measurements<br> <br> Genetic: Telomerase activity on a blood sample<br> <br> Other: Quality of life (questionnaires)<br> <br> Other: Cerebral IRMf<br> <br> |
| Experimental: Endurance training program (8 weeks) group<br>only physical training group | Other: Endurance exercise training<br>* In each group, there will be a comparison of aerobic capacity, quality of life (with questionnaires), functional cerebral measurements (fRMI), and telomerase activity between before and after the 8 weeks program<br>Other: Vo2max measurements<br> <br> Genetic: Telomerase activity on a blood sample<br> <br> Other: Quality of life (questionnaires)<br> <br> Other: Cerebral IRMf<br> <br> |
| Experimental: MBSR group (mindfulness-based-stress-reduction)<br>only mental training group (8 weeks) | Other: Mindfulness-based-stress-reduction<br> <br> |
| Experimental: Endurance training program combined with MBSR sessions<br>Endurance training program combined with MBSR sessions, during 8 weeks (mindfulness-based-stress-reduction) | Other: Both interventions together<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of V02 max between inclusion and 8 weeks | effect of physical training associated with mental work on physical abilities of patients | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise capacity, Mindfulness, Quality of life