Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT00486525|
Recruitment Status : Completed
First Posted : June 14, 2007
Results First Posted : April 10, 2014
Last Update Posted : May 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Depression Fatigue Pain||Procedure: Yoga Therapy||Not Applicable|
- To determine if the yoga intervention will decrease inflammation, fatigue, and depressive symptoms relative to the waiting-list controls in women who are stage 0-IIIa breast cancer survivors.
OUTLINE: Patients are stratified according to stage of cancer (stage 0 vs stage I vs stage II and stage IIIA) and prior radiation therapy (yes vs no). Patients are randomized to 1 of 2 intervention arms.
- Arm I (waiting-list control): Patients are encouraged to perform usual activities, but asked to refrain from any yoga practice or other related activities. After a six-month observation period, patients undergo yoga intervention as described in arm II .
- Arm II (yoga intervention): Patients participate in a Hatha yoga intervention session comprising body postures and breath control techniques for 1.5 hours twice a week for 12 weeks. Patients are encouraged to practice Hatha yoga at home. Patients complete daily diaries on home Hatha yoga practices and submit them at each session.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||March 2013|
Experimental: Arm I: Yoga Therapy
Patients 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.
Procedure: Yoga Therapy
Patients will undergo yoga therapy
Other Name: Yoga
No Intervention: Arm II: Wait-List
Wait-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.
- Stimulated ln (TNF-a) [ Time Frame: Immediately post-treatment and 3 months post-treatment ]log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)
- Stimulated ln (IL-6) [ Time Frame: Immediately post-treatment and 3 months post-treatment ]log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)
- Stimulated ln (IL-1b) [ Time Frame: Immediately post-treatment and 3 months post-treatment ]log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)
- MFSI-SF Fatigue [ Time Frame: Immediately post-treatment and 3 months post-treatment ]
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.
- Vitality, SF-36 [ Time Frame: Immediately post-treatment and 3 months post-treatment ]
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.
- CES-D [ Time Frame: Immediately post-treatment and 3 months post-treatment ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486525
|United States, Ohio|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210-1240|
|Study Chair:||Janice Kiecolt-Glaser, PhD||Ohio State University Comprehensive Cancer Center|