Breast CancerMBSRNCT02900326
Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help in Treatment for Breast Cancer
A study testing Endurance exercise training, Mindfulness-based-stress-reduction and Both interventions together in people with Breast Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Endurance exercise training, Mindfulness-based-stress-reduction and Both interventions together
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2015to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer
- Having completed the chemotherapy period
- Undergoing radiotherapy and/or hormono therapy
Who cannot join
- Regular physical activity higher than 4 hours per week.
- Any disease cardiac, respiratory, neurological or articular disease, which counteract the muscular training )
Trial locations and contacts
1 site in 1 country.
France1 site
Physiologie et EFR/ EA 3072 mitochondrie, stress oxydant et protection musculaire
Strasbourg, 67091
About this study
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
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.
- Conditions
- Breast Cancer
- Being tested
- Endurance exercise training, Mindfulness-based-stress-reduction, Both interventions together, Vo2max measurements, Telomerase activity on a blood sample
- Keywords
- Exercise capacity, Mindfulness, Quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance exercise trainingOther
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
Mindfulness-based-stress-reductionOther
Both interventions togetherOther
Vo2max measurementsOther
Telomerase activity on a blood sampleGenetic
Quality of life (questionnaires)Other
Cerebral IRMfOther
| Study group | Role | What they receive |
|---|---|---|
| Control patients with no intervention | Placebo comparator | group without intervention Receives: Other: Vo2max measurements; Genetic: Telomerase activity on a blood sample; Other: Quality of life (questionnaires); Other: Cerebral IRMf |
| Endurance training program (8 weeks) group | Experimental | only physical training group Receives: Other: Endurance exercise training; Other: Vo2max measurements; Genetic: Telomerase activity on a blood sample; Other: Quality of life (questionnaires); Other: Cerebral IRMf |
| MBSR group (mindfulness-based-stress-reduction) | Experimental | only mental training group (8 weeks) Receives: Other: Mindfulness-based-stress-reduction |
| Endurance training program combined with MBSR sessions | Experimental | Endurance training program combined with MBSR sessions, during 8 weeks (mindfulness-based-stress-reduction) Receives: Other: Both interventions together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of V02 max between inclusion and 8 weeks
effect of physical training associated with mental work on physical abilities of patients
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start12 May 2015
- Primary completion12 May 2015
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LONSDORFER Evelyne, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900326
- Sponsor's protocol ID
- 5970
- Acronym
- MBSR
- Status last verified
- Dec 2025
- First submitted
- 16 Jun 2015
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37590246
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02900326
- Acronym / sponsor ID
- MBSR / 5970
- Conditions
- Breast Cancer
- Keywords
- Exercise capacity, Mindfulness, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 12 May 2015 (actual)
- Primary completion
- 12 May 2015 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control patients with no intervention | Placebo comparator | Other: Vo2max measurements, Genetic: Telomerase activity on a blood sample, Other: Quality of life (questionnaires), Other: Cerebral IRMfgroup without intervention |
| Endurance training program (8 weeks) group | Experimental | Other: Endurance exercise training, Other: Vo2max measurements, Genetic: Telomerase activity on a blood sample, Other: Quality of life (questionnaires), Other: Cerebral IRMfonly physical training group |
| MBSR group (mindfulness-based-stress-reduction) | Experimental | Other: Mindfulness-based-stress-reductiononly mental training group (8 weeks) |
| Endurance training program combined with MBSR sessions | Experimental | Other: Both interventions togetherEndurance training program combined with MBSR sessions, during 8 weeks (mindfulness-based-stress-reduction) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Breast cancer
- Having completed the chemotherapy period
- Undergoing radiotherapy and/or hormono therapy
Key exclusion criteria (2 listed)
- Regular physical activity higher than 4 hours per week.
- Any disease cardiac, respiratory, neurological or articular disease, which counteract the muscular training )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurance exercise trainingIn 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 | Endurance training program (8 weeks) group |
| Mindfulness-based-stress-reduction | Other | MBSR group (mindfulness-based-stress-reduction) |
| Both interventions together | Other | Endurance training program combined with MBSR sessions |
| Vo2max measurements | Other | Control patients with no intervention, Endurance training program (8 weeks) group |
| Telomerase activity on a blood sample | Genetic | Control patients with no intervention, Endurance training program (8 weeks) group |
| Quality of life (questionnaires) | Other | Control patients with no intervention, Endurance training program (8 weeks) group |
| Cerebral IRMf | Other | Control patients with no intervention, Endurance training program (8 weeks) group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 37590246Sibeoni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LONSDORFER Evelyne principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance exercise training, Mindfulness-based-stress-reduction and Both interventions together in people with Breast Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of V02 max between inclusion and 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02900326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.