Trial Information

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

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 I-IIIa
breast cancer survivors.

Secondary

- 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
measurement.