MedDataX Logo

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

NCT ID: NCT02900326

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-12

Study Completion Date

2021-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Exercise capacity Mindfulness Quality of life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control patients with no intervention

group without intervention

Group Type PLACEBO_COMPARATOR

Vo2max measurements

Intervention Type OTHER

Telomerase activity on a blood sample

Intervention Type GENETIC

Quality of life (questionnaires)

Intervention Type OTHER

Cerebral IRMf

Intervention Type OTHER

Endurance training program (8 weeks) group

only physical training group

Group Type EXPERIMENTAL

Endurance exercise training

Intervention Type OTHER

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

Vo2max measurements

Intervention Type OTHER

Telomerase activity on a blood sample

Intervention Type GENETIC

Quality of life (questionnaires)

Intervention Type OTHER

Cerebral IRMf

Intervention Type OTHER

MBSR group (mindfulness-based-stress-reduction)

only mental training group (8 weeks)

Group Type EXPERIMENTAL

Mindfulness-based-stress-reduction

Intervention Type OTHER

Endurance training program combined with MBSR sessions

Endurance training program combined with MBSR sessions, during 8 weeks (mindfulness-based-stress-reduction)

Group Type EXPERIMENTAL

Both interventions together

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Mindfulness-based-stress-reduction

Intervention Type OTHER

Both interventions together

Intervention Type OTHER

Vo2max measurements

Intervention Type OTHER

Telomerase activity on a blood sample

Intervention Type GENETIC

Quality of life (questionnaires)

Intervention Type OTHER

Cerebral IRMf

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 )
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

LONSDORFER Evelyne

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Physiologie et EFR/ EA 3072 mitochondrie, stress oxydant et protection musculaire

Strasbourg, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Sibeoni J, Manolios E, Mathe J, Feka V, Vinez MM, Lonsdorfer-Wolf E, Bloch JG, Bayle F, Meunier JP, Revah-Levy A, Verneuil L. The experience of a program combining two complementary therapies for women with breast cancer: An IPSE qualitative study. PLoS One. 2023 Aug 17;18(8):e0285617. doi: 10.1371/journal.pone.0285617. eCollection 2023.

Reference Type RESULT
PMID: 37590246 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5970

Identifier Type: -

Identifier Source: org_study_id