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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01686737
Recruitment Status : Withdrawn (Recruitment problems)
First Posted : September 18, 2012
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen

Tracking Information
First Submitted Date  ICMJE September 12, 2012
First Posted Date  ICMJE September 18, 2012
Last Update Posted Date February 5, 2013
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2012)
Fatigue [ Time Frame: Week 12 ]
Multidimensional Fatigue Inventory
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2012)
  • Fatigue [ Time Frame: Week 36 ]
    Multidimensional Fatigue Inventory
  • Health-related quality of life [ Time Frame: Week 12, week 36 ]
    Functional Assessment of Cancer Therapy - Breast
  • Depression and anxiety [ Time Frame: Week 12, week 36 ]
    Hospital Anxiety and Depression Scale
  • Sleep quality [ Time Frame: Week 12, week 36 ]
    Pittsburgh Sleep Quality Index
  • Perceived Stress [ Time Frame: Week 12, week 36 ]
    • Perceived Stress Scale
    • Impact of Event Scale
  • Salivary Cortisol [ Time Frame: Week 12, week 36 ]
    Cortisol awakening response
  • Safety [ Time Frame: Week 0-36 ]
    Adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients
Official Title  ICMJE Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Neoplasms
  • Fatigue
Intervention  ICMJE
  • Behavioral: Iyengar Yoga
    • 12 weeks of Iyengar yoga
    • 2 weekly sessions of 60 minutes
  • Behavioral: Walking
    • 12 weeks of walking
    • 2 weekly sessions of 60 minutes
Study Arms  ICMJE
  • Experimental: Yoga

    Iyengar Yoga

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

    Walking

    • 12 weeks of walking
    • 2 weekly sessions of 60 minutes
    Intervention: Behavioral: Walking
  • No Intervention: Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 4, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2012)
126
Estimated Study Completion Date  ICMJE July 2014
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01686737
Other Study ID Numbers  ICMJE 2012210
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Holger Cramer, Universität Duisburg-Essen
Study Sponsor  ICMJE Universität Duisburg-Essen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Universität Duisburg-Essen
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP