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

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ClinicalTrials.gov Identifier: NCT02900326
Recruitment Status : Unknown
Verified September 2016 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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?
Study Start Date : May 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control patients with no intervention
group without intervention
Other: Vo2max measurements
Genetic: Telomerase activity on a blood sample
Other: Quality of life (questionnaires)
Other: Cerebral IRMf
Experimental: Endurance training program (8 weeks) group
only physical training group
Other: Endurance exercise training
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

Other: Vo2max measurements
Genetic: Telomerase activity on a blood sample
Other: Quality of life (questionnaires)
Other: Cerebral IRMf
Experimental: MBSR group (mindfulness-based-stress-reduction)
only mental training group(8 weeks)
Other: Mindfulness-based-stress-reduction
Experimental: Endurance training program combined with MBSR sessions
Endurance training program combined with MBSR sessions, during 8 weeks (mindfulness-based-stress-reduction)
Other: Both interventions together



Primary Outcome Measures :
  1. Evolution of V02 max between inclusion and 8 weeks [ Time Frame: 8 weeks ]
    effect of physical training associated with mental work on physical abilities of patients



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer
  • Finished with chemotherapy treatment
  • 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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900326


Contacts
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Contact: LONSDORFER Evelyne, MD 0369550880 evelyne.lonsdorfer@chru-strasbourg.fr

Locations
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France
Physiologie et EFR/ EA 3072 mitochondrie, stress oxydant et protection musculaire Recruiting
Strasbourg, France, 67091
Contact: PETIT Thierry, MD    0388252424    TPetit@strasbourg.unicancer.fr   
Principal Investigator: LONSDORFER Evelyne, MD         
Sub-Investigator: BARTHELEMY Philippe, MD         
Sub-Investigator: BLOCH Jean-Gérard, MD         
Sub-Investigator: GENY Bernard, MD         
Sub-Investigator: DiMARCO Paola, MD         
Sub-Investigator: ENACHE Irina, MD         
Sub-Investigator: TALHA Samy, MD         
Sub-Investigator: ZOLL Joffrey, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02900326     History of Changes
Other Study ID Numbers: 2014-A01681-46
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Strasbourg, France:
Exercise capacity
Mindfulness
Quality of life
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases