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Yoga Breathing for Fatigue in Patients Undergoing Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anand Dhruva, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00982748
First received: September 18, 2009
Last updated: August 23, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to determine the feasibility and efficacy of yoga breathing techniques to manage fatigue and other cancer-related side effects, in cancer patients undergoing chemotherapy.


Condition Intervention
Breast Cancer
 Behavioral: Pranayama (Yoga Breathing) Techniques

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Pranayama on Fatigue Among Patients Undergoing Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Feasibility [ Time Frame: Baseline and second cycle of chemotherapy ] [ Designated as safety issue: No ]
    Feasibility will be evaluated based on recruitment, retention, completion of study classes and home practice, and completion of study measures


Secondary Outcome Measures:
  • Cancer associated symptoms and quality of life [ Time Frame: baseline and final cycle of chemotherapy ] [ Designated as safety issue: No ]
    fatigue, sleep, stress, anxiety and depression quality of life


Estimated Enrollment: 25
Study Start Date: October 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group B
Study participants in this arm attend yoga breathing classes once per week over the span of one chemotherapy cycle.
 Behavioral: Pranayama (Yoga Breathing) Techniques
1-hour long yoga breathing classes, taught once per week for 2-8 consecutive weeks. Dose (Number of classes) administered is dependent on randomization arm and individuals' chemotherapy cycle length.
Experimental: Group A
Participants in this study arm attend weekly yoga breathing classes during two consecutive cycles of chemotherapy
 Behavioral: Pranayama (Yoga Breathing) Techniques
1-hour long yoga breathing classes, taught once per week for 2-8 consecutive weeks. Dose (Number of classes) administered is dependent on randomization arm and individuals' chemotherapy cycle length.

Detailed Description:

Fatigue is the most common complaint among cancer patients. This pilot study will evaluate the effects of pranayama (ancient yoga breathing techniques) on fatigue and quality of life among 30 patients undergoing chemotherapy, on an every 2, 3, or 4 week schedule, with a fatigue score of at least 4 on a scale of 0 (none) to 10 (most). Patients will be randomized to either pranayama or wait-list control. The pranayama group will learn and practice 3 breathing techniques on a daily basis. The study period will occur during 2 consecutive cycles of chemotherapy (cycle A and Cycle B), and the wait-list control patients will crossover to the treatment arm at the beginning of his/her Cycle B. Fatigue will be measured using the revised Piper Fatigue Scale along with quality of life measures. These study measures will be conducted at baseline, at the end of cycle A, and at the end of cycle B. We hypothesize that pranayama will improve clinical symptoms of fatigue and quality of life among patients undergoing chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of cancer that requires at least 2 further cycles of chemotherapy on an every 14, 21, or 28 day schedule
  • A score of at least 4/10 on a 0-10 (0-none, 10-most) visual analog scale for fatigue at the time of enrollment
  • Able to read, write and understand English
  • Karnofsky Performance Status greater than 60
  • Ability to give informed consent

Exclusion Criteria:

  • Severe COPD
  • Receiving chronic oxygen therapy
  • Congestive heart failure: NYHA class 3 or greater
  • Transfusion dependent anemia
  • Uncontrolled thyroid disease
  • Advance kidney disease requiring dialysis
  • Advance liver disease
  • More than three previous chemotherapy regimens
  • Current, ongoing yoga breathing practice
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982748

Locations
United States, California
Osher Center for Integrative Medicine, UCSF
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Anand Dhruva, Assistant Clinical Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00982748     History of Changes
Other Study ID Numbers: 08803, Mt.Zion Healthfund 20070658
Study First Received: September 18, 2009
Last Updated: August 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Fatigue
Chemotherapy
Yoga
Breathing
Cancer
 Anxiety
Pranayama
Stress
Fatigue-associated symptoms in chemotherapy patients
Quality of life in chemotherapy patients

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

ClinicalTrials.gov processed this record on May 16, 2013