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

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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Recruitment Status : Withdrawn (Recruitment problems)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

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.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Fatigue Behavioral: Iyengar Yoga Behavioral: Walking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients
Study Start Date : November 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

No Intervention: Usual Care



Primary Outcome Measures :
  1. Fatigue [ Time Frame: Week 12 ]
    Multidimensional Fatigue Inventory


Secondary Outcome Measures :
  1. Fatigue [ Time Frame: Week 36 ]
    Multidimensional Fatigue Inventory

  2. Health-related quality of life [ Time Frame: Week 12, week 36 ]
    Functional Assessment of Cancer Therapy - Breast

  3. Depression and anxiety [ Time Frame: Week 12, week 36 ]
    Hospital Anxiety and Depression Scale

  4. Sleep quality [ Time Frame: Week 12, week 36 ]
    Pittsburgh Sleep Quality Index

  5. Perceived Stress [ Time Frame: Week 12, week 36 ]
    • Perceived Stress Scale
    • Impact of Event Scale

  6. Salivary Cortisol [ Time Frame: Week 12, week 36 ]
    Cortisol awakening response

  7. Safety [ Time Frame: Week 0-36 ]
    Adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686737


Locations
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Germany
Klinik für Senologie / Brustzentrum, Kliniken Essen-Mitte
Essen, Germany, 45136
Brustzentrum Köln-Hohenlind, St. Elisabeth-Krankenhaus Köln-Hohenlind
Köln, Germany, 50935
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
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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

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Responsible Party: Holger Cramer, Postdoctoral fellow, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01686737     History of Changes
Other Study ID Numbers: 2012210
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
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Breast Neoplasms
Fatigue
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases