Clinical trial NCT00982748: Yoga Breathing for Fatigue in Patients Undergoing Chemotherapy
Official title: Effects of Pranayama on Fatigue Among Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Fatigue
Chemotherapy
Yoga
Breathing
Cancer
Anxiety
Pranayama
Stress
Fatigue-associated symptoms in chemotherapy patients
Quality of life in chemotherapy patients
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Feasibility
timeFrame: Baseline and second cycle of chemotherapy
Secondary outcomes:
measure: Cancer associated symptoms and quality of life
timeFrame: baseline and final cycle of chemotherapy
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Osher Center for Integrative Medicine, UCSF
state: California
Study officials:
References:
citation: Dhruva A, Miaskowski C, Abrams D, Acree M, Cooper B, Goodman S, Hecht FM. Yoga breathing for cancer chemotherapy-associated symptoms and quality of life: results of a pilot randomized controlled trial. J Altern Complement Med. 2012 May;18(5):473-9. doi: 10.1089/acm.2011.0555. Epub 2012 Apr 23.