Yoga Breathing for Fatigue in Patients Undergoing Chemotherapy
August 23, 2011 updated by: Anand Dhruva, University of California, San Francisco
Effects of Pranayama on Fatigue Among Patients Undergoing Chemotherapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
25
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
-
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California
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San Francisco, California, United States, 94115
- Osher Center for Integrative Medicine, UCSF
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group B
Study participants in this arm attend yoga breathing classes once per week over the span of one chemotherapy cycle.
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility
Time Frame: Baseline and second cycle of chemotherapy
|
Feasibility will be evaluated based on recruitment, retention, completion of study classes and home practice, and completion of study measures
|
Baseline and second cycle of chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cancer associated symptoms and quality of life
Time Frame: baseline and final cycle of chemotherapy
|
fatigue, sleep, stress, anxiety and depression quality of life
|
baseline and final cycle of chemotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
September 18, 2009
First Submitted That Met QC Criteria
September 22, 2009
First Posted (Estimate)
September 23, 2009
Study Record Updates
Last Update Posted (Estimate)
August 25, 2011
Last Update Submitted That Met QC Criteria
August 23, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08803
- Mt.Zion Healthfund 20070658
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.