Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors
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.
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.
Study Design
Allocation: Randomized, Control: Active Control, Masking: Double-Blind, Primary Purpose: Supportive Care
Conditions
Breast Cancer
Intervention
chromatography, flow cytometry, immunoenzyme technique, examination, fatigue assessment and management, management of therapy complications, psychosocial assessment and care, quality-of-life assessment, yoga therapy
Location
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus
Ohio
United States
43210-1240
Status
Recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00486525
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Image Cytometry
A technique encompassing morphometry, densitometry, neural networks, and expert systems that has numerous clinical and research applications and is particularly useful in anatomic pathology for the study of malignant lesions. The most common current application of image cytometry is for DNA analysis, followed by quantitation of immunohistochemical staining.
Immunophenotyping
Process of classifying cells of the immune system based on structural and functional differences. The process is commonly used to analyze and sort T-lymphocytes into subsets based on CD antigens by the technique of flow cytometry.
Gas Chromatography-mass Spectrometry
A microanalytical technique combining mass spectrometry and gas chromatography for the qualitative as well as quantitative determinations of compounds.
Chromatography, Reverse-phase
A chromatography technique in which the stationary phase is composed of a non-polar substance with a polar mobile phase, in contrast to normal-phase chromatography in which the stationary phase is a polar substance with a non-polar mobile phase.
Q-sort
A personality assessment technique in which the subject or observer indicates the degree to which a standardized set of descriptive statements actually describes the subject. The term reflects "sorting" procedures occasionally used with this technique.
Clinical Trials
Aflibercept in Treating Patients With Myelodysplastic Syndromes
RATIONALE: Aflibercept may be able to carry cancer-killing substances directly to myelodysplastic syndrome cells. It may also stop the growth of cancer cells by blocking blood flow to the...
Evaluation of Patients Who Have Skin Diseases
RATIONALE: Evaluating patients who have skin diseases may help doctors plan more effective treatment and follow-up for skin diseases and systemic diseases that show up in the skin. PURPOS...
Study of Proteins in Head and Neck Cancer Cells
RATIONALE: Studying proteins in head and neck cancer cells in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. P...
RATIONALE: VEGF Trap may be able to carry cancer-killing substances directly to multiple myeloma cells. It may also stop the growth of multiple myeloma by blocking blood flow to the cancer...
Vaccine Therapy in Treating Patients With Recurrent B-Cell Lymphoma
RATIONALE: Vaccines made from mouse DNA may help the body build an effective immune response to kill cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose o...
PubMed Articles
Minimally invasive assessment of tumor angiogenesis by fine needle aspiration and flow cytometry.
The development of a new, less invasive, and more rapidly implemented method of quantifying endothelial cell density in tumors could facilitate experimental and clinical studies of angiogenesis. There...
Flow cytometry of intestinal intraepithelial lymphocytes in celiac disease.
This article reviews the multiple uses of flow cytometry in the diagnosis, monitoring and research of celiac disease, the most prevalent chronic autoimmune gastrointestinal disease. The phenotyping of...
We report a rare case of chronic myeloid leukemia in accelerated phase with basophilic transformation, in which basophils exceeding 70%, were detectable only by flow cytometry because of their morphol...
The aim of this study was to compare the techniques of indirect immunofluorescence assay (IFA) and flow cytometry to clinical and laboratorial evaluation of patients before and after clinical cure and...
Abstract Reliable detection of leptomeningeal disease has the potential of facilitating the diagnosis of CNS lymphoma and is important for therapeutic considerations. Currently, the standard diagnosti...
