NCT01908270
Completed
Not Applicable
Randomized Controlled Trial of Yoga for Menopausal Symptoms in Women With Breast Cancer
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Menopausal symptoms
Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Regular yoga practice in the past 12 months
- •Planned surgery in the study period
- •Diagnosed and medically treated psychosis
- •Hormone replacement therapy
Outcomes
Primary Outcomes
Menopausal symptoms
Time Frame: Week 12
Menopause Rating Scale
Secondary Outcomes
- Anxiety(Week 24)
- Health-related quality of life (disease-specific)(Week 24)
- Depression(Week 24)
- Menopausal symptoms(Week 24)
- Adverse events(Week 24)
- Fatigue(Week 24)
Investigators
Holger Cramer
Research Fellow
Universität Duisburg-Essen
Study Sites (1)
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