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Paced breathing for hot flashes in breast cancer survivors: a randomized Phase II study
Psycho-Social and Complementary Treatment
Breast cancer survivors commonly experience hot flashes that have a negative impact on patient’s quality of survivorship. The treatment options for hot flashes in these patients are limited. The pathophysiology of hot flashes involves a narrowing of the thermoneutral zone that is partly mediated by an increased central adrenergic drive. Paced breathing (slow, deep and diaphragmatic) is reported to reduce central sympathetic activity and facilitate a relaxation response. A program of paced breathing is reported to improve symptoms of hot flashes in pilot clinical trials involving post-menopausal women. The optimal duration of this program that is likely to provide the maximal effect size in breast cancer survivors is not presently known. In the present study, 75 patients with a history of breast cancer in remission, who are experiencing >14 hot flashes/week will be randomized to practice one of the two programs of paced breathing (15 minutes once a day vs. 15 minutes twice a day) or usual breathing for 8-weeks. After an initial training period, patients will be provided an audio tape to practice the breathing program at home. Primary efficacy outcomes include feasibility and compliance with this intervention along with the effect of paced breathing on hot flash scores. Secondary outcomes include a change in mood states, fatigue, and sleep quality. The study will provide the data to plan an R01 submission for a larger, multi-center, definitive clinical trial, if the results from this study seem promising.
Hot flashes are a common symptom in patients who have been previously treated for breast cancer. Hormone treatments (i.e. estrogen) are generally not given to these patients for the fear of stimulating growth of breast cancer. Thus, effective treatment options for hot flash symptoms in breast cancer survivors are limited. An increased output of adrenaline from the brain is considered as one of the mechanisms for the production of hot flashes. A pharmacologic treatment, i.e. clonidine that works by reducing this output is shown to be effective for improving hot flashes. A similar effect has been suggested in a small number of patients provided with a program of paced breathing. Paced breathing involves slow, deep, diaphragmatic breathing that facilitates a relaxation response, lowers blood pressure and is shown in pilot trials to improve hot flash symptoms. The optimal program of paced breathing likely to provide the maximal benefit in improving hot flashes in breast cancer survivors is not presently known. The present study will test two different programs of paced breathing (15 minutes once a day vs. 15 minutes twice a day), compared to a program of usual breathing, for improving hot flashes in 75 women who are breast cancer survivors and experiencing >14 hot flashes/week. Patients will be randomly assigned to paced breathing or usual breathing and, after initial training, will be provided an audio tape to practice the program on their own. The primary outcomes of the study will include the ability of the patients to practice paced breathing and the suggested effect of paced breathing on hot flashes. Secondary outcomes include the suggested effects of paced breathing on mood, energy level and sleep quality. If paced breathing seems promising in this study, a larger study will be designed to definitively test this treatment for improving hot flashes in breast cancer survivors.