Yoga Breathing for Fatigue in Patients Undergoing Chemotherapy

Breast Cancer Clinical Trial

Official title:

Effects of Pranayama on Fatigue Among Patients Undergoing Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982748
• Other study ID #: 08803
• Secondary ID: Mt.Zion Healthfu
• Status: Completed
• Phase: N/A
• First received: September 18, 2009
• Last updated: August 23, 2011
• Start date: October 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2011
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Osher Center for Integrative Medicine, UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	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	No
Secondary	Cancer associated symptoms and quality of life	fatigue, sleep, stress, anxiety and depression quality of life	baseline and final cycle of chemotherapy	No