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

The Ohio State University

Status: Completed

Conditions: Breast Cancer; Depression; Fatigue; Pain

Treatments: Procedure: Yoga Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00486525

OSU-06137

R01CA126857 (U.S. NIH Grant/Contract)

NCI-2012-00564 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Arm I: Yoga Therapy

Experimental group

Description:

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.

Treatment:

Procedure: Yoga Therapy

Arm II: Wait-List

No Intervention group

Description:

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.