The Women’s Hormones and Aging Research Program (WHARP) is a clinical and translational research group at Brigham & Women's Hospital in Boston, MA, that aims to advance our understanding and treatment of symptoms resulting from changes in reproductive hormones in the brain. These include affective disturbance, sleep disruption, hot flashes, fatigue, cognitive performance, and more recently, changes in metabolism and appetite. We use clinical trial, observational, and experimental paradigms in humans to study the biological basis of these symptoms and strategies to optimize treatment.
Current Research During the Menopause Transition
Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in Women Currently Enrolling
This study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. We hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia Currently Enrolling
The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.
Psychological and autonomic hyperarousal in menopausal hot flash-associated insomnia Completed Accrual
This is a cross-sectional study comparing the psychological and physiologic profiles of hyperarousal among perimenopausal and postmenopausal women with vs. without insomnia.
Stress response in midlife women with hot flashes Completed Accrual
This study aims to characterize stress response in both peri- and postmenopausal women who either are or are not suffering from hot flashes. We also aim to determine which measures of anxiety best correlate with hot flashes in these women.
Effects of estradiol and hot flashes on mood in perimenopausal women (completed accrual)
This observational study looks at changes in estradiol levels and depression symptoms in perimenopausal and premenopausal women. The aim is to determine whether hot flashes are an important intermediary in the generation of perimenopause-associated depression.
Current Research in the Breast Cancer Population
Study Of Fatigue In Patients on palbociclib Currently Enrolling
This observational study of patients with metastatic breast cancer aims to investigate the development and course of fatigue during the first 6 months of palbociclib combination therapy. We also will examine the patient perspective on fatigue and other effects of palbociclib combination therapy on quality of life.
Predicting Hot Flash and Quality of Life Response To Breast Cancer Therapies Currently Enrolling
The goal of this observational study is to identify psychological traits, sleep patterns, and tamoxifen metabolism/genetic characteristics that predict the development of hot flashes and decline in quality of life among breast cancer patients on endocrine therapy.
Testing the Feasibility of a remotely administered behavioral intervention to improve quality of life among early stage breast cancer patients Currently Enrolling
As an optional nested cohort within the observational study described above, this study is investigating whether a remotely administered cognitive behavioral intervention is a feasible method of addressing possible psychological predictors of quality of life decline.
Phase IIB double-blind placebo controlled trial of naltrexone for treatment-emergent fatigue in patients receiving radiation for breast cancer Monitoring phase Completed Accrual; Intervention phase Terminated
This project investigates the incidence and predictors of radiotherapy-related fatigue in breast cancer patients.