Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors
Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
3 other identifiers
interventional
200
1 country
1
Brief Summary
RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors. PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Aug 2007
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2007
CompletedFirst Posted
Study publicly available on registry
June 14, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
April 10, 2014
CompletedMay 5, 2014
April 1, 2014
5.3 years
June 13, 2007
November 14, 2013
April 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Stimulated ln (TNF-a)
log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)
Immediately post-treatment and 3 months post-treatment
Stimulated ln (IL-6)
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)
Immediately post-treatment and 3 months post-treatment
Stimulated ln (IL-1b)
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)
Immediately post-treatment and 3 months post-treatment
MFSI-SF Fatigue
The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue. Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue.
Immediately post-treatment and 3 months post-treatment
Vitality, SF-36
The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month. Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue.
Immediately post-treatment and 3 months post-treatment
CES-D
The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale. Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.
Immediately post-treatment and 3 months post-treatment
Study Arms (2)
Arm I: Yoga Therapy
EXPERIMENTALPatients participate in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients are also encouraged to practice yoga at home using the appropriate DVD/video segments for the month.
Arm II: Wait-List
NO INTERVENTIONWait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
Interventions
Eligibility Criteria
You may qualify if:
- Hemoglobin ≥ 10 g/dL (patients with a hemoglobin of \< 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered)
- Physically able to fully participate in yoga intervention
You may not qualify if:
- Inability to comfortably get up and down from the floor 2-3 times in a session
- Breathing problems requiring use of oxygen
- Problems walking without a cane or walker assistance
- Prior knee or hip replacement with limited movement in the joint
- Inability to comfortably lie on the stomach
- Alcohol, or drug abuse
- Diagnosis of any of the following conditions:
- Diabetes
- Chronic obstructive pulmonary disease
- Uncontrolled hypertension
- Evidence of liver or kidney failure
- Symptomatic ischemic heart disease
- Significant visual or auditory problems
- Mental disorder or cognitive impairment
- Notable serious cardiovascular history (e.g., prior life-threatening abnormal heart rhythms)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240, United States
Related Publications (1)
Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10):1040-9. doi: 10.1200/JCO.2013.51.8860. Epub 2014 Jan 27.
PMID: 24470004RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
We did not compare yoga to an active control group; Fatigue and depressive symptoms were not used as part of the inclusion criteria. Accordingly, our data may underestimate yoga's potential benefit.
Results Point of Contact
- Title
- Janice Kiecolt-Glaser, Principal Investigator
- Organization
- Ohio State University Comprehensive Cancer Center
Study Officials
- STUDY CHAIR
Janice Kiecolt-Glaser, PhD
Ohio State University Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 13, 2007
First Posted
June 14, 2007
Study Start
August 1, 2007
Primary Completion
November 1, 2012
Study Completion
March 1, 2013
Last Updated
May 5, 2014
Results First Posted
April 10, 2014
Record last verified: 2014-04