Breast Cancer Clinical Trial
— MBSROfficial title:
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
| NCT number | NCT02900326 |
| Other study ID # | 5970 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 12, 2015 |
| Est. completion date | March 30, 2021 |
| Verified date | May 2022 |
| Source | University Hospital, Strasbourg, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | March 30, 2021 |
| Est. primary completion date | May 12, 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 ) |
| Country | Name | City | State |
|---|---|---|---|
| France | Physiologie et EFR/ EA 3072 mitochondrie, stress oxydant et protection musculaire | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evolution of V02 max between inclusion and 8 weeks | effect of physical training associated with mental work on physical abilities of patients | 8 weeks |
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