Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

1. To determine if the yoga intervention will decrease inflammation, fatigue, and depressive symptoms relative to the waiting-list controls in women who are stage I-IIIa breast cancer survivors.

Secondary

1. To determine the extent to which the yoga intervention modulates psychological, behavioral, and physical functioning in these patients.
2. To evaluate the relationship between depressive symptoms and the magnitude of the physiological responses elicited by a laboratory stressor, as well as the relationship of both to fatigue in these patients.
3. To assess the extent to which the yoga intervention will decrease physiological stress responses in these patients.

Entry Criteria

Disease Characteristics:

• Stage 0-IIIA breast cancer survivor

• Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase inhibitors)
  • Must have received chemotherapy or radiotherapy OR surgery only, as part of treatment
  • 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

Prior/Concurrent Therapy:

• See Disease Characteristics
• No regular use of medications with major immunological consequences (e.g., steroids)

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
• Body mass index (BMI) ≥ 40
• 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 cancer

Expected Enrollment

Outcomes

Proinflammatory cytokines
Fatigue
Depressive symptoms

Psychological (quality of life, perceived stress, and stress responsiveness)
Behavioral (health behaviors)
Physical functioning (physical symptoms, pain, flexibility, and functional status)
Physiological stress responses (NF-κB and proinflammatory cytokine responses to a laboratory stressor assessed at baseline)

Outline

This is a multicenter study. Patients are stratified according to stage of cancer (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 with the support of appropriate monthly DVD/video segments. Patients complete daily diaries on home Hatha yoga practices and submit them at each session.

In both arms, patients are physically assessed, interviewed, and then complete heath and health-related behavior questionnaires regarding psychological (quality of life, perceived stress, and stress responsiveness), behavioral (health behaviors), physical functioning (physical symptoms, pain, flexibility, and functional status), and physiological stress responses (NF-κB and proinflammatory cytokine responses to a laboratory stressor) at baseline, 3 months, and 6 months.

Patients undergo fasting blood sample collection at baseline, 3 months, and 6 months to analyze fatty acid composition of plasma by gas chromatography, changes in immune function, proinflammatory cytokine, and key inflammation markers of fatigue and stress by ELISA, flow cytometry, and indirect immunofluorescence (IF) test. Additionally, patient response to laboratory stressors are assessed at baseline using the Trier Social Stress Test (TSST). Saliva samples are collected periodically and before and after the TSST for cortisol level measurement.

Trial Contact Information

Trial Lead Organizations

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Janice Kiecolt-Glaser, PhD, Protocol chair		Ph: 614-293-3499

Registry Information
Official Title		Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
Trial Start Date		2007-08-01
Trial Completion Date		2013-08-01 (estimated)
Registered in ClinicalTrials.gov		NCT00486525
Date Submitted to PDQ		2007-08-15
Information Last Verified		2012-05-01
NCI Grant/Contract Number		CA0126857, CA16058

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