Yoga Breathing for Fatigue in Patients Undergoing Chemotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Pranayama on Fatigue Among Patients Undergoing Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Pranayama (Yoga Breathing) Techniques


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group B<br>Study participants in this arm attend yoga breathing classes once per week over the span of one chemotherapy cycle. | Behavioral: Pranayama (Yoga Breathing) Techniques<br>* 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.<br>|
| Experimental: Group A<br>Participants in this study arm attend weekly yoga breathing classes during two consecutive cycles of chemotherapy | Behavioral: Pranayama (Yoga Breathing) Techniques<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer associated symptoms and quality of life | fatigue, sleep, stress, anxiety and depression quality of life | baseline and final cycle of chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Chemotherapy, Yoga, Breathing, Cancer, Anxiety, Pranayama, Stress, Fatigue-associated symptoms in chemotherapy patients, Quality of life in chemotherapy patients