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Clinical Trials/NCT01908270
NCT01908270
Completed
Not Applicable

Randomized Controlled Trial of Yoga for Menopausal Symptoms in Women With Breast Cancer

Universität Duisburg-Essen1 site in 1 country40 target enrollmentStarted: August 2013Last updated:

Overview

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Holger Cramer

Research Fellow

Universität Duisburg-Essen

Study Sites (1)

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