Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary 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.

Official Title
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Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress

Conditions
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Fatigue, Breast Cancer, Depression, Pain

Intervention / Treatment
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* Procedure: Yoga Therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Stage 0-IIIA breast cancer survivor Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase inhibitors) At least 2 months since prior surgery, adjuvant therapy, or radiotherapy, whichever occurred last Women who are not currently practicing yoga and have not participated in any of the following activities: Meditation, tai chi, or related activities Yoga or tai chi within the past 6 months Had classes for or practiced yoga for more than 3 months Women who typically engage in a total of 5 or more hours of vigorous physical activity per week are not eligible No inflammatory breast cancer PATIENT CHARACTERISTICS: Inclusion criteria: 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 Exclusion criteria: 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) Other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis History of breast or any other cancer, except basal or squamous cell skin cancer PRIOR CONCURRENT THERAPY: See Disease Characteristics No regular use of medications with major immunological consequences (e.g., steroids)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I: Yoga Therapy<br>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<br>* Patients will undergo yoga therapy<br>* Other names: Yoga;|
| No Intervention: Arm II: Wait-List<br>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. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, depression, pain, cancer survivor, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, breast cancer in situ