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

21 Years
Open (Enrolling)
Breast Cancer, Cancer Survivor, Depression, Fatigue, Pain

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Trial Information

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



- 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.


- To determine the extent to which the yoga intervention modulates psychological,
behavioral, and physical functioning in these patients.

- 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.

- To assess the extent to which the yoga intervention will decrease physiological stress
responses in these patients.

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

Inclusion Criteria


- Stage 0-IIIA breast cancer survivor

- Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase

- Must have received chemotherapy or radiotherapy OR surgery only, as part of

- 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


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

- 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


- See Disease Characteristics

- No regular use of medications with major immunological consequences (e.g., steroids)

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Proinflammatory cytokines

Principal Investigator

Janice Kiecolt-Glaser, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Cancer Survivor
  • Depression
  • Fatigue
  • Pain
  • 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
  • Breast Neoplasms
  • Depression
  • Depressive Disorder
  • Fatigue
  • Inflammation



Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240