Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Postmenopausal Breast Cancer Survivors - Full Text View

Sponsors and Collaborators:	Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00526526

Purpose

RATIONALE: Yoga may improve inflammation, fatigue, and depression in postmenopausal breast cancer survivors.

PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in postmenopausal breast cancer survivors.

Condition	Intervention
Breast Cancer Cancer-Related Problem/Condition Fatigue Pain	Other: chromatography Other: flow cytometry Other: immunoenzyme technique Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: observation Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: yoga therapy

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Active Control
Official Title:	Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Proinflammatory cytokines
Fatigue
Depressive symptoms

Secondary Outcome Measures:

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)

Estimated Enrollment:	250
Study Start Date:	August 2007
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

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 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Stage I-IIIA breast cancer survivor
Completed cancer treatment within the past 24 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 diagnosed lymphedema
No inflammatory breast cancer
Hormone receptor status not specified

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
Prior history of breast or any other cancer, except basal or squamous cell cancer

PRIOR CONCURRENT THERAPY:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526526

Locations

United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com

Sponsors and Collaborators

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Janice Kiecolt-Glaser, PhD

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000562452, OSU-2007C0004, OSU-06137
Study First Received:	September 5, 2007
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00526526 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

fatigue
depression
pain

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Study placed in the following topic categories:

Signs and Symptoms
Depression
Fatigue
Skin Diseases
Breast Neoplasms

Pain
Depressive Disorder
Breast Diseases
Inflammation

Additional relevant MeSH terms:

Signs and Symptoms
Neoplasms
Pathologic Processes
Neoplasms by Site
Fatigue

Skin Diseases
Breast Neoplasms
Breast Diseases
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009