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Effects of Yoga on Menopausal Symptoms in Women With Breast Cancer

NCT ID: NCT01908270

Last Updated: 2014-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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Menopause Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Yoga

Yoga intervention 12 weeks, weekly 90-minute intervention Yoga postures, breathing, relaxation, and meditation

Group Type EXPERIMENTAL

Yoga

Intervention Type BEHAVIORAL

Usual care

Intervention Type OTHER

Usual care

Patients continue usual care by their practitioner

Group Type OTHER

Usual care

Intervention Type OTHER

Interventions

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Yoga

Intervention Type BEHAVIORAL

Usual care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Holger Cramer

Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Holger Cramer, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Essen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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13-5421-BO

Identifier Type: -

Identifier Source: org_study_id