Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors
|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|
|Breast Cancer Depression Fatigue Pain||Procedure: Yoga Therapy|
- 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|
|Primary Completion Date :||November 2012|
|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.
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|