Yoga in Decreasing Inflammation, Fatigue, and Depressive Symptoms in Breast Cancer Survivors
Basic Trial Information
|Phase II||Biomarker/Laboratory analysis, Supportive care||21 and over||OSU-06137|
NCI-2012-00564, 2007C0004, OSU-2007C0004, NCT00486525
Breast cancer survivors confront a number of post-treatment problems; fatigue is the most common problem reported by survivors. Although there are many possible causes for post-treatment fatigue, there is growing evidence that persistent fatigue may be related in part to overactivation of an important part of the immune system, the inflammatory network. Physical activity interventions that enhance physical performance can reduce fatigue as well as inflammation. The current study is designed to examine whether yoga offers both psychological and physical benefits for cancer survivors. In particular, we are interested in whether yoga will decrease inflammation, decrease fatigue, and improve mood.
Further Study Information
I. To determine if the yoga intervention will decrease inflammation, fatigue, and depressive symptoms relative to the wait-list controls.
I. To ascertain the extent to which the yoga intervention modulates psychological, behavioral, and physical functioning.
II. 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.
III. To assess the extent to which the yoga intervention will decrease physiological stress responses.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients are also encouraged to practice yoga at home using the appropriate DVD/video segments for the month.
ARM II: Patients do not participate in yoga sessions or related activities.
After completion of study treatment, patients are followed up annually.
Women who cannot comfortably get up and down from the floor 2-3 times in a session will be excluded
Women who cannot comfortably lie on their belly will be excluded (a potential problem for those who are very overweight), and thus we will exclude any with a body mass index (BMI) of 40 or larger
Women who have had knee or hip replacement may be excluded if they have limited movement in the joint
We will exclude individuals with notable serious cardiovascular histories, e.g., those who have had life-threatening abnormal heart rhythms
Other exclusions will include: a prior history of breast or any other cancer except basal or squamous cell, inflammatory breast cancer, diabetes, chronic obstructive pulmonary disease, uncontrolled hypertension, evidence of liver or kidney failure, symptomatic ischemic heart disease, significant visual or auditory problems, mental disorder, cognitive impairment, other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, alcohol or drug abuse, or regular use of medications with major immunological consequences, e.g., steroids
We would prefer to avoid recruitment of women who are taking beta blockers, including catecholamine and nuclear factor of kappa light polypeptide gene enhancer in B-cells (NF-kB) responses; however, if recruitment concerns dictate their inclusion, we can use beta blocker use as a grouping variable, following work which showed significant exercise-related cytokine changes in individuals who were taking beta blockers
Antidepressant use will not be an exclusion criteria
Women will be recruited who are not currently practicing yoga, meditation, tai chi, or related activities and who had not had classes in yoga or tai chi within the last six months, and who had never practiced yoga for more than three months
We will exclude women who report that they typically engage in a total of 5 or more hours of vigorous physical activity per week
Each participant will be screened for anemia at the screening session; women will only be eligible for the study if they have a hemoglobin level >= 10 g/dl; if a woman is found to be anemic at the screening session, she will be asked to see her physician; she will have the option of being retested for anemia in 6 weeks; if she is no longer anemic, she would be eligible for participation.
Participants who are initially determined to be eligible may be removed from the study at a later date if the yoga instructors or research staff have reason to believe that the yoga sessions or other parts of the study could be unsafe for the participant in some way
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
Ohio State University Comprehensive Cancer Center
- National Cancer Institute
Ohio State University Comprehensive Cancer Center
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00486525
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.