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.