Effects of Yoga on Menopausal Symptoms in Women With Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01908270
First received: July 23, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Menopause
Breast Cancer
Behavioral: Yoga
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Yoga for Menopausal Symptoms in Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • Menopausal symptoms [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Menopause Rating Scale


Secondary Outcome Measures:
  • Health-related quality of life (disease-specific) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Functional Assessment of Cancer Therapy - Breast

  • Fatigue [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Functional Assessment of Chronic Illness Therapy - Fatigue

  • Anxiety [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale

  • Depression [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale

  • Menopausal symptoms [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Menopause Rating Scale

  • Health-related quality of life (disease-specific) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Functional Assessment of Cancer Therapy - Breast

  • Fatigue [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Functional Assessment of Chronic Illness Therapy - Fatigue

  • Anxiety [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale

  • Depression [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale

  • Adverse events [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Appraisal of body [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Fragebogen zur Beurteilung des Körpers (Questionnaire for the assessment of body)

  • Appraisal of body [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Fragebogen zur Beurteilung des Körpers (Questionnaire for the assessment of body)

  • Body awareness [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Body Awareness Questionnaire

  • Body awareness [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Body Awareness Questionnaire

  • Self-esteem [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Self-esteem scale

  • Self-esteem [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Self-esteem scale

  • Adherence [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Course adherence and daily home practice

  • Adherence [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Daily home practice


Enrollment: 40
Study Start Date: August 2013
Estimated Study Completion Date: February 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga
Yoga intervention 12 weeks, weekly 90-minute intervention Yoga postures, breathing, relaxation, and meditation
Behavioral: Yoga Other: Usual care
Usual care
Patients continue usual care by their practitioner
Other: Usual care

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01908270

Locations
Germany
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Essen, Germany, 45276
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Holger Cramer, Research Fellow, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01908270     History of Changes
Other Study ID Numbers: 13-5421-BO
Study First Received: July 23, 2013
Last Updated: December 10, 2013
Health Authority: Germany: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 22, 2014