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Completed

NCT Number: NCT01908270

Effects of Yoga on 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.

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Key information

Conditions

Menopause Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Essen, 45276, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga

Behavioral

Usual Care

Other

Primary outcomes

  1. Menopausal symptoms

    Time frame: Week 12

    Menopause Rating Scale

Secondary outcomes

  1. Health-related quality of life (disease-specific)

    Time frame: Week 12

    Functional Assessment of Cancer Therapy - Breast

  2. Fatigue

    Time frame: Week 12

    Functional Assessment of Chronic Illness Therapy - Fatigue

  3. Anxiety

    Time frame: Week 12

    Hospital Anxiety and Depression Scale

  4. Depression

    Time frame: Week 12

    Hospital Anxiety and Depression Scale

  5. Menopausal symptoms

    Time frame: Week 24

    Menopause Rating Scale

  6. Health-related quality of life (disease-specific)

    Time frame: Week 24

    Functional Assessment of Cancer Therapy - Breast

  7. Fatigue

    Time frame: Week 24

    Functional Assessment of Chronic Illness Therapy - Fatigue

  8. Anxiety

    Time frame: Week 24

    Hospital Anxiety and Depression Scale

  9. Depression

    Time frame: Week 24

    Hospital Anxiety and Depression Scale

  10. Adverse events

    Time frame: Week 12

  11. Adverse events

    Time frame: Week 24

Other outcomes

  1. Appraisal of body

    Time frame: Week 12

    Fragebogen zur Beurteilung des Körpers (Questionnaire for the assessment of body)

  2. Appraisal of body

    Time frame: Week 24

    Fragebogen zur Beurteilung des Körpers (Questionnaire for the assessment of body)

  3. Body awareness

    Time frame: Week 12

    Body Awareness Questionnaire

  4. Body awareness

    Time frame: Week 24

    Body Awareness Questionnaire

  5. Self-esteem

    Time frame: Week 12

    Self-esteem scale

  6. Self-esteem

    Time frame: Week 24

    Self-esteem scale

  7. Adherence

    Time frame: Week 12

    Course adherence and daily home practice

  8. Adherence

    Time frame: Week 24

    Daily home practice

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jul 25, 2013
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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