NCT01908270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

3 months

First QC Date

July 23, 2013

Last Update Submit

July 30, 2014

Conditions

MenopauseBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Menopausal symptoms

    Menopause Rating Scale

    Week 12

Secondary Outcomes (11)

  • Health-related quality of life (disease-specific)

    Week 12

  • Fatigue

    Week 12

  • Anxiety

    Week 12

  • Depression

    Week 12

  • Menopausal symptoms

    Week 24

  • +6 more secondary outcomes

Other Outcomes (8)

  • Appraisal of body

    Week 12

  • Appraisal of body

    Week 24

  • Body awareness

    Week 12

  • +5 more other outcomes

Study Arms (2)

Yoga

EXPERIMENTAL

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

Behavioral: YogaOther: Usual care

Usual care

OTHER

Patients continue usual care by their practitioner

Other: Usual care

Interventions

YogaBEHAVIORAL
Yoga
Usual careOTHER
Usual careYoga

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Regular yoga practice in the past 12 months
  • Planned surgery in the study period
  • Diagnosed and medically treated psychosis
  • Hormone replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Essen, 45276, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Holger Cramer, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 25, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2013

Study Completion

February 1, 2014

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

DE(1)