Yoga Breathing for Fatigue in Patients Undergoing Chemotherapy

NCT ID: NCT00982748

Last Updated: 2011-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group B

Study participants in this arm attend yoga breathing classes once per week over the span of one chemotherapy cycle.

Group Type: ACTIVE_COMPARATOR

Pranayama (Yoga Breathing) Techniques

Intervention Type: BEHAVIORAL

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.

Group A

Participants in this study arm attend weekly yoga breathing classes during two consecutive cycles of chemotherapy

Group Type: EXPERIMENTAL

Pranayama (Yoga Breathing) Techniques

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Anand Dhruva

Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Osher Center for Integrative Medicine, UCSF

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22525009 (View on PubMed)

Other Identifiers

Mt.Zion Healthfund 20070658

Identifier Type: -

Identifier Source: secondary_id

08803

Identifier Type: -

Identifier Source: org_study_id