Clinical trial NCT00486525: Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors
Official title: Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Depression
Fatigue
Pain
Keywords: 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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-06-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility 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)

Primary outcomes:
measure: Stimulated ln (TNF-a)
timeFrame: Immediately post-treatment and 3 months post-treatment
measure: Stimulated ln (IL-6)
timeFrame: Immediately post-treatment and 3 months post-treatment
measure: Stimulated ln (IL-1b)
timeFrame: Immediately post-treatment and 3 months post-treatment
measure: MFSI-SF Fatigue
timeFrame: Immediately post-treatment and 3 months post-treatment
measure: Vitality, SF-36
timeFrame: Immediately post-treatment and 3 months post-treatment
measure: CES-D
timeFrame: Immediately post-treatment and 3 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Janice Kiecolt-Glaser, PhD
role: STUDY_CHAIR
References:
citation: Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10):1040-9. doi: 10.1200/JCO.2013.51.8860. Epub 2014 Jan 27.