Effects of Pranayama on Fatigue Among Patients Undergoing Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Feasibility
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group B
Study participants in this arm attend yoga breathing classes once per week over the span of one chemotherapy cycle.
Intervention: Pranayama (Yoga Breathing) Techniques (Behavioral)
Group A
Participants in this study arm attend weekly yoga breathing classes during two consecutive cycles of chemotherapy
Intervention: Pranayama (Yoga Breathing) Techniques (Behavioral)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Cancer associated symptoms and quality of life(baseline and final cycle of chemotherapy)
Investigators
Anand Dhruva
Assistant Clinical Professor
University of California, San Francisco