Effects of Yoga on Menopausal Symptoms in Women With Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer; Menopause
• Interventions: Behavioral: Yoga; Other: Usual care

• Registration Number: NCT01908270
• Lead Sponsor: Universität Duisburg-Essen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-25
• Study Start: 2013-08
• Primary Completion: 2013-11
• Study Completion: 2014-02
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-30
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga	Yoga	Yoga intervention 12 weeks, weekly 90-minute intervention Yoga postures, breathing, relaxation, and meditation
Usual care	Usual care	Patients continue usual care by their practitioner
Yoga	Usual care	Yoga intervention 12 weeks, weekly 90-minute intervention Yoga postures, breathing, relaxation, and meditation

Primary Outcome Measures

Name	Time	Method
Menopausal symptoms	Week 12	Menopause Rating Scale

Secondary Outcome Measures

Name	Time	Method
Anxiety	Week 24	Hospital Anxiety and Depression Scale
Health-related quality of life (disease-specific)	Week 24	Functional Assessment of Cancer Therapy - Breast
Depression	Week 24	Hospital Anxiety and Depression Scale
Menopausal symptoms	Week 24	Menopause Rating Scale
Adverse events	Week 24
Fatigue	Week 24	Functional Assessment of Chronic Illness Therapy - Fatigue

Trial Locations

Locations (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen; 🇩🇪 Essen, Germany