Effects of Yoga on Menopausal Symptoms in Women With Breast Cancer

July 30, 2014 updated by: Holger Cramer, Universität Duisburg-Essen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany, 45276
        • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual care
Patients continue usual care by their practitioner
Other: Usual care
Experimental: Yoga
Yoga intervention 12 weeks, weekly 90-minute intervention Yoga postures, breathing, relaxation, and meditation
Other: Usual care
Behavioral: Yoga

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menopausal symptoms
Time Frame: Week 12
Menopause Rating Scale
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Week 12
Week 12
Health-related quality of life (disease-specific)
Time Frame: Week 12
Functional Assessment of Cancer Therapy - Breast
Week 12
Fatigue
Time Frame: Week 12
Functional Assessment of Chronic Illness Therapy - Fatigue
Week 12
Anxiety
Time Frame: Week 12
Hospital Anxiety and Depression Scale
Week 12
Depression
Time Frame: Week 12
Hospital Anxiety and Depression Scale
Week 12
Menopausal symptoms
Time Frame: Week 24
Menopause Rating Scale
Week 24
Health-related quality of life (disease-specific)
Time Frame: Week 24
Functional Assessment of Cancer Therapy - Breast
Week 24
Fatigue
Time Frame: Week 24
Functional Assessment of Chronic Illness Therapy - Fatigue
Week 24
Anxiety
Time Frame: Week 24
Hospital Anxiety and Depression Scale
Week 24
Depression
Time Frame: Week 24
Hospital Anxiety and Depression Scale
Week 24
Adverse events
Time Frame: Week 24
Week 24

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appraisal of body
Time Frame: Week 12
Fragebogen zur Beurteilung des Körpers (Questionnaire for the assessment of body)
Week 12
Appraisal of body
Time Frame: Week 24
Fragebogen zur Beurteilung des Körpers (Questionnaire for the assessment of body)
Week 24
Body awareness
Time Frame: Week 12
Body Awareness Questionnaire
Week 12
Body awareness
Time Frame: Week 24
Body Awareness Questionnaire
Week 24
Self-esteem
Time Frame: Week 12
Self-esteem scale
Week 12
Self-esteem
Time Frame: Week 24
Self-esteem scale
Week 24
Adherence
Time Frame: Week 12
Course adherence and daily home practice
Week 12
Adherence
Time Frame: Week 24
Daily home practice
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität Duisburg-Essen

Investigators

  • Principal Investigator: Holger Cramer, PhD, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 24, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-5421-BO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Usual care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe