Research During the Menopause Transition
- Brain Health and Hot Flashes in Postmenopausal Women
- Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in Women
- Efficacy of Suvorexant in the Treatment of Hot Flash-Associated Insomnia
- Psychological and Autonomic Hyperarousal in Menopausal Hot Flash-Associated Insomnia
- Stress Response in Midlife Women with Hot Flashes
- Effects of Estradiol and Hot Flashes on Mood in Perimenopausal Women
Currently Enrolling
This study will advance the health of postmenopausal women by determining stress responses, neural processes, and neurobiological mechanisms that are affected when hot flashes occur and persist.
This project is part of the Brigham/Harvard Reproductive Outcomes of Stress and Aging (ROSA) Center in the BWH Connors Center for Women’s Health and Gender Biology.
If you are interested in participating, please click here for more details.
Completed Accrual
This NIH-funded clinical research 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.
Completed Accrual
The aim of this study is to determine the effect of suvorexant, an FDA-approved medication, on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.
Participants completed 4 visits and were randomized to receive either study drug or a placebo. Participants took a daily pill for 4 weeks to complete the trial.
Related publications:
Manuscript in progress
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.
Related publications:
Bertisch, SM et al. Cardiovascular reactivity and psychological hyperarousal in hot flash-associated insomnia disorder. Menopause 2019 Jan 21.
https://www.ncbi.nlm.nih.gov/pubmed/30672883
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.
Related Publications:
Nathan MD, Wiley A, Mahon PB, Camuso J, Sullivan K, McCormick K, Srivastava A, Albert K, Newhouse P, Joffe H. Hypothalamic-pituitary-adrenal axis, subjective, and thermal stress responses in midlife women with vasomotor symptoms. Menopause. 2020 Dec 14;28(4):439-443. doi: 10.1097/GME.0000000000001703. PMID: 33323762.
https://pubmed.ncbi.nlm.nih.gov/33323762/
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.
Related Publications:
Joffe H, de Wit A, Coborn J, Crawford S, Freeman M, Wiley A, Athappilly G, Kim S, Sullivan KA, Cohen LS, Hall JE. Impact of Estradiol Variability and Progesterone on Mood in Perimenopausal Women With Depressive Symptoms. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e642–50. doi: 10.1210/clinem/dgz181. PMID: 31693131; PMCID: PMC7075107.
https://pubmed.ncbi.nlm.nih.gov/31693131/
de Wit AE, Giltay EJ, de Boer MK, Nathan M, Wiley A, Crawford S, Joffe H. Predictors of irritability symptoms in mildly depressed perimenopausal women. Psychoneuroendocrinology. 2021 Apr; 126:105128. doi: 10.1016/j.psyneuen.2021.105128. Epub 2021 Jan 7. PMID: 33493755.
https://pubmed.ncbi.nlm.nih.gov/33493755/
Research In The Breast Cancer Population
- Study of Fatigue in Patients on Palbociclib
- Predicting Hot Flash And Quality Of Life Response To Breast Cancer Therapies
- Testing The Feasibility Of A Remotely Administered Behavioral Intervention To Improve Quality Of Life Among Early Stage Breast Cancer Patients
- Phase IIB Double-Blind Placebo Controlled Trial Of Naltrexone For Treatment-Emergent Fatigue In Patients Receiving Radiation For Breast Cancer
Completed Accrual
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.
This study is being conducted at Dana Farber Cancer Institute and Brigham and Women’s Hospital.
Related Publications:
Manuscript in progress
Completed Accrual
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.
Women with Stage 1 or 2 breast cancer who were starting tamoxifen or aromatase inhibitors were enrolled. Study participation included completing surveys four times over 7 months and brief daily hot flash diaries for the first 8 weeks on hormone therapies, as well as the option to wear a sleep monitor for one week at 3 time points.
This study was conducted at Dana Farber Cancer Institute and Brigham and Women’s Hospital.
Related Publications:
Yusufov M, Nathan M, Wiley A, Russell J, Partridge A, Joffe H. Predictors of increased risk for early treatment non-adherence to oral anti-estrogen therapies in early-stage breast cancer patients. Breast Cancer Res Treat. 2021 Jan;185(1):53-62. doi: 10.1007/s10549-020-05920-y. Epub 2020 Sep 12. PMID: 32918659.
https://pubmed.ncbi.nlm.nih.gov/32918659/
Completed Accrual
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.
Related Publications:
Manuscript in progress
Monitoring Phase Completed Accrual; Intervention Phase Terminated
This project investigates the incidence and predictors of radiotherapy-related fatigue in breast cancer patients.