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Yoga Breathing for Fatigue in Patients Undergoing Chemotherapy

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pranayama (Yoga Breathing) Techniques
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Fatigue, Chemotherapy, Yoga, Breathing, Cancer, Anxiety, Pranayama, Stress, Fatigue-associated symptoms in chemotherapy patients, Quality of life in chemotherapy patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Osher Center for Integrative Medicine, UCSF

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group B

Group A

Arm Description

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

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

Outcomes

Primary Outcome Measures

Feasibility
Feasibility will be evaluated based on recruitment, retention, completion of study classes and home practice, and completion of study measures

Secondary Outcome Measures

Cancer associated symptoms and quality of life
fatigue, sleep, stress, anxiety and depression quality of life

Full Information

First Posted
September 18, 2009
Last Updated
August 23, 2011
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00982748
Brief Title
Yoga Breathing for Fatigue in Patients Undergoing Chemotherapy
Official Title
Effects of Pranayama on Fatigue Among Patients Undergoing Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Fatigue, Chemotherapy, Yoga, Breathing, Cancer, Anxiety, Pranayama, Stress, Fatigue-associated symptoms in chemotherapy patients, Quality of life in chemotherapy patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Study participants in this arm attend yoga breathing classes once per week over the span of one chemotherapy cycle.
Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants in this study arm attend weekly yoga breathing classes during two consecutive cycles of chemotherapy
Intervention Type
Behavioral
Intervention Name(s)
Pranayama (Yoga Breathing) Techniques
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility
Description
Feasibility will be evaluated based on recruitment, retention, completion of study classes and home practice, and completion of study measures
Time Frame
Baseline and second cycle of chemotherapy
Secondary Outcome Measure Information:
Title
Cancer associated symptoms and quality of life
Description
fatigue, sleep, stress, anxiety and depression quality of life
Time Frame
baseline and final cycle of chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Osher Center for Integrative Medicine, UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22525009
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.
Results Reference
derived

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Yoga Breathing for Fatigue in Patients Undergoing Chemotherapy

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