Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients (IFaB)

February 4, 2013 updated by: Holger Cramer, Universität Duisburg-Essen

Breast cancer is the most frequent cancer in women and is associated with profound restrictions of health-related quality of life and psychosocial health. More than three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While exercise interventions can improve fatigue in breast cancer patients, many patients request complementary treatment approaches. Therefore, this study investigates the effects of yoga in women with breast cancer compared to aerobic exercise and usual care.

It is hypothesized that yoga is more effective than usual care and equally effective as aerobic exercise.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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, 45136
        • Klinik für Senologie / Brustzentrum, Kliniken Essen-Mitte
      • Köln, Germany, 50935
        • Brustzentrum Köln-Hohenlind, St. Elisabeth-Krankenhaus Köln-Hohenlind

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • non-metastatic invasive breast cancer
  • currently receiving adjuvant chemotherapy
  • moderate to severe chemotherapy-induced fatigue
  • physical and cognitive capacity to participate in yoga or walking

Exclusion Criteria:

  • diagnosed and pharmacologically treated psychiatric disorder except depressive adaptation disorder as a reaction to cancer diagnosis
  • ECOG status > 1
  • prior malignancy with a disease-free survival < 10 years except curatively treated basalioma of the skin and carcinoma in situ of the cervix
  • prior ductal carcinoma in situ (DCIS) ot the breast
  • pregnancy or breastfeeding
  • regular practice of yoga or walking during the past 12 months

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
No Intervention: Usual Care
Experimental: Yoga

Iyengar Yoga

  • 12 weeks of Iyengar yoga
  • 2 weekly sessions of 60 minutes
Behavioral: Iyengar Yoga
  • 12 weeks of Iyengar yoga
  • 2 weekly sessions of 60 minutes
Active Comparator: Aerobic exercise

Walking

  • 12 weeks of walking
  • 2 weekly sessions of 60 minutes
Behavioral: Walking
  • 12 weeks of walking
  • 2 weekly sessions of 60 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Week 12
Multidimensional Fatigue Inventory
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Week 36
Multidimensional Fatigue Inventory
Week 36
Health-related quality of life
Time Frame: Week 12, week 36
Functional Assessment of Cancer Therapy - Breast
Week 12, week 36
Depression and anxiety
Time Frame: Week 12, week 36
Hospital Anxiety and Depression Scale
Week 12, week 36
Sleep quality
Time Frame: Week 12, week 36
Pittsburgh Sleep Quality Index
Week 12, week 36
Perceived Stress
Time Frame: Week 12, week 36
  • Perceived Stress Scale
  • Impact of Event Scale
Week 12, week 36
Salivary Cortisol
Time Frame: Week 12, week 36
Cortisol awakening response
Week 12, week 36
Safety
Time Frame: Week 0-36
Adverse events
Week 0-36

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, University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
  • Study Director: Gustav J. Dobos, MD, University of Duisburg-Essen, Chair of Complementary and Integrative Medicine

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

November 1, 2012

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 12, 2012

First Posted (Estimate)

September 18, 2012

Study Record Updates

Last Update Posted (Estimate)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012210

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.

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