MenopauseNCT01908270
Effects of Yoga on Menopausal Symptoms in Women With Breast Cancer
A study testing Yoga in people with Menopause and Breast Cancer, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
Women with breast cancer and breast cancer survivors are often bothered by menopausal symptoms to a special degree. Treatment options for those symptoms are currently limited as hormone replacement therapy is often prohibited. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Menopause, Breast Cancer
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Feb 2014
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer (Stage I-III)
- After completion of surgical therapy
- After completion of adjuvant radiotherapy and chemotherapy
- Score of 5 or greater on the Menopausal Rating Scale
- Physical and cognitive capacity to participate in the yoga intervention
- Willingness to participate in 10 or more of the 12 yoga interventions
- signed informed consent
Who cannot join
- Regular yoga practice in the past 12 months
- Planned surgery in the study period
- Diagnosed and medically treated psychosis
- Hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Essen, 45276
About this study
Official title: Randomized Controlled Trial of Yoga for Menopausal Symptoms in Women With Breast Cancer
Women with breast cancer and breast cancer survivors are often bothered by menopausal symptoms to a special degree. Treatment options for those symptoms are currently limited as hormone replacement therapy is often prohibited. Yoga has been shown to reduce menopausal symptoms as well as symptoms associated with breast cancer. Therefore, this study aims to investigate whether a 12-week yoga intervention can reduce menopausal symptoms in women with breast cancer and breast cancer survivors.
- Conditions
- Menopause, Breast Cancer
- Being tested
- Yoga, Usual care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Usual careOther
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Yoga intervention 12 weeks, weekly 90-minute intervention Yoga postures, breathing, relaxation, and meditation Receives: Behavioral: Yoga; Other: Usual care |
| Usual care | Other | Patients continue usual care by their practitioner Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopausal symptoms
Menopause Rating Scale
Measured: Week 12
Secondary outcomes (11)
Health-related quality of life (disease-specific)
Functional Assessment of Cancer Therapy - Breast
Measured: Week 12
Fatigue
Functional Assessment of Chronic Illness Therapy - Fatigue
Measured: Week 12
Anxiety
Hospital Anxiety and Depression Scale
Measured: Week 12
Depression
Hospital Anxiety and Depression Scale
Measured: Week 12
Menopausal symptoms
Menopause Rating Scale
Measured: Week 24
Health-related quality of life (disease-specific)
Functional Assessment of Cancer Therapy - Breast
Measured: Week 24
Fatigue
Functional Assessment of Chronic Illness Therapy - Fatigue
Measured: Week 24
Anxiety
Hospital Anxiety and Depression Scale
Measured: Week 24
Depression
Hospital Anxiety and Depression Scale
Measured: Week 24
Adverse events
Measured: Week 12
Adverse events
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
- Investigators
- Holger Cramer, PhD, Principal investigator, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908270
- Sponsor's protocol ID
- 13-5421-BO
- Status last verified
- Jul 2014
- First submitted
- 23 Jul 2013
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Yoga for Menopausal Symptoms in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT01908270
- Acronym / sponsor ID
- 13-5421-BO
- Conditions
- Menopause, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Jul 2013 (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.
Women with breast cancer and breast cancer survivors are often bothered by menopausal symptoms to a special degree. Treatment options for those symptoms are currently limited as hormone replacement therapy is often prohibited. Yoga has been shown to reduce menopausal symptoms as well as symptoms associated with breast cancer. Therefore, this study aims to investigate whether a 12-week yoga intervention can reduce menopausal symptoms in women with breast cancer and breast cancer survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Yoga, Other: Usual careYoga intervention 12 weeks, weekly 90-minute intervention Yoga postures, breathing, relaxation, and meditation |
| Usual care | Other | Other: Usual carePatients continue usual care by their practitioner |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Breast cancer (Stage I-III)
- After completion of surgical therapy
- After completion of adjuvant radiotherapy and chemotherapy
- Score of 5 or greater on the Menopausal Rating Scale
- Physical and cognitive capacity to participate in the yoga intervention
Key exclusion criteria (4 listed)
- Regular yoga practice in the past 12 months
- Planned surgery in the study period
- Diagnosed and medically treated psychosis
- Hormone replacement therapy
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 |
|---|---|---|
| Yoga | Behavioural | Yoga |
| Usual care | Other | Usual care, Yoga |
Primary outcome
Menopausal symptoms
Time frame: Week 12
Menopause Rating Scale
11 secondary outcomes
Health-related quality of life (disease-specific)
Time frame: Week 12
Fatigue
Time frame: Week 12
Anxiety
Time frame: Week 12
Depression
Time frame: Week 12
Menopausal symptoms
Time frame: Week 24
Health-related quality of life (disease-specific)
Time frame: Week 24
Fatigue
Time frame: Week 24
Anxiety
Time frame: Week 24
Depression
Time frame: Week 24
Adverse events
Time frame: Week 12
Adverse events
Time frame: Week 24
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 31 Jul 2014.
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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.
Holger Cramer, PhD principal investigator
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Menopause and Breast Cancer, run by Universität Duisburg-Essen at 1 site in Germany.
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 7 inclusion and 4 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 31 Jul 2014. 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 Germany. 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. 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?
Menopausal symptoms (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2014.