Connecticut Breast Health Initiative

The University of Connecticut Health Center

Translational Mechanisms of Bone Loss in Postmenopausal Women with Breast Cancer Undergoing Treatment with Aromatase Inhibitors

Awarded $30,000

About this Project:

Aromatase inhibitors (AIs) are first line agents for the treatment of breast cancer and are known to cause a decrease in bone mineral density (BMD). Our study goal was to understand the translational mechanisms of bone loss in postmenopausal women on AIs for breast cancer. We hypothesized that decreases in estrogen with these agents would be associated with increased bone turnover and decreased BMD as a result of increased bone resorption, mediated by increased receptor activated nuclear factor kappa B (NF-kB) ligand (RANKL).  Use of AIs in postmenopausal women with breast cancer was associated with a decrease in estrogen levels, a significant increase in bone resorption and formation, and a significant decrease in lumbar spine BMD. These changes occurred with a significant increase in RANKL levels and an increased RANKL/OPG ratio. The negative correlation between bone formation and BMD suggests that the intrinsic response of bone formation to increased resorption determines the magnitude of change in BMD in these women.

The University of Connecticut Health Center

Trial of Vaginal Estrogen for Urogenital Symptom Relief in Women on Aromatase Inhibitors; Systemic Impact Versus Local Objective Benefits and Quality of Life

Awarded $50,000

About this Project:  

Postmenopausal women often suffer from natural loss of estrogen when going through the menopause. One particular organ system that is impacted significantly by estrogen loss is the urogenital system, specifically the ability of the bladder and vaginal tissues to function normally. Symptoms including vaginal dryness, urinary tract infection, and sexual dysfunction are a result of estrogen loss in many postmenopausal women.  Another organ system which is impacted significantly by estrogen loss is the skeletal system. Bone loss in women is highest at menopause.  These problems are compounded in millions of women who are on anti-estrogen medications for the prevention or treatment of breast cancer. Women with breast cancer often deny themselves estrogen replacement due to the fear of cancer or its’ recurrence. We propose a topical vaginal estrogen application (one commercially available) with careful monitoring of its’ effects locally in the vagina, its’ impact on blood hormone levels and its’ possible impact on bone health, a distant site. It is impossible to know what impact a given estrogen level has in distant sites and by looking at bone health, we can get a sense of changes in an distant end organ that is impacted by estrogen. If bone is impacted at a distance in a positive way (reduced bone loss), one might consider that there might be a negative impact on any cancer still present (growth of the tumor). If bones are not impacted in this pilot study but urogenital symptoms and quality of life of our patients improve, a larger trial should be entertained to confirm the efficacy and safety of this treatment.  Our proposed study will be carried out by the multidisciplinary interaction of our survivor program, gynecologic (GYN) oncology group, breast oncology team and our bone endocrinologists.  Our teams have been integrated both clinically and in translational research studies for several years.

Yale School of Public Health

The Lifestyle, Exercise and Nutrition (LEAN) Study

Awarded $49,972

About this Project:

Dr. Melinda Irwin’s CTBHI research project is focused on improving lifestyle factors (weight, exercise and diet) in women diagnosed with breast cancer. Women who are obese at the time of breast cancer diagnosis have a higher risk of recurrence and mortality compared with normal weight women. To date, only a few diet- and exercise-induced weight loss trials in breast cancer survivors have been published.  We recently completed a six-month diet- and exercise-induced randomized weight loss trial in 100 overweight breast cancer survivors who had completed adjuvant treatment, entitled the Lifestyle, Exercise and Nutrition (LEAN) Study. We found statistically significant decreases in body weight and serum biomarkers among women randomized to weight loss.  Anecdotally, study participants in the weight loss groups were very enthusiastic about the study and, in particular, they reported that they found the LEAN book invaluable. Many women asked for a copy of the LEAN book to give to other breast cancer survivors. However, we have been hesitant in recommending the LEAN book until we have evidence-based findings on weight loss with the LEAN book alone, i.e., independent of the counseling sessions. Thus, we propose modifying the LEAN intervention to make it more cost effective by reducing or eliminating the counseling sessions, and conducting a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC breast cancer survivors examining 6-month changes in body weight, diet, physical activity, and quality of life in women randomized to receive the LEAN book and videos compared to women randomized to wait-list control (i.e., the wait-list control will receive the LEAN book/videos after completing the 6-month study). We will also examine weight changes 6-months post-intervention, and predictors of weight loss at 6- and 12-months. Results from our study will provide evidence-based findings on how much weight loss is feasible when intervening via the LEAN book/videos. If efficacious, we will disseminate the LEAN book/videos more widely, with confidence of its utility. We envision working with cancer foundations (including CTBHI), cancer centers and hospitals to distribute the intervention to breast cancer survivors, which in turn, may lower overweight and obesity rates and may improve breast cancer outcomes.

The Hispanic Center of Greater Danbury, Inc.

The Hispanic Center Breast Cancer Program

Awarded $24,978

About this Project:  

The Hispanic Center seeks to promote breast health education through culturally competent and sensitive community outreach and awareness. The Hispanic Center Breast Cancer Project is a program designed for minority woman living in or working in the Greater Danbury area. We provide breast health education and psychosocial support for minority woman and their families facing breast cancer.

The Hospital of Central Connecticut

Healthy Lifestyles:  A Breast Health program for women at increased risk, those currently undergoing treatment, and breast cancer survivors (education and research).

Awarded $19,500

About this Project: 

Epidemiologic studies have demonstrated that lifestyle factors play an important role in breast cancer incidence and prevalence as well as recurrence, and that at least some of these factors are readily modifiable.  Physical activity and diet/nutrition have been found to be two very important lifestyle factors that can modify the risk of breast cancer.  In addition, exercise and dietary changes have been shown to improve quality of life and reduce secondary complications of the treatment of breast cancer.  As part of the ongoing development of breast program, we would like to develop a healthy lifestyles program for our survivors, women going through treatment and those who are at an elevated risk.  This program will focus on educating women about the importance of nutrition and exercise and assist them in making the modifications to their life-styles that will make a difference in their long-term health and survival.   

The proposed Healthy Lifestyles program will be tailored to each individual woman, therefore not only can healthy survivors participate but so will those currently beginning or going through treatment.  Woman with all levels of fitness will be able to participate.  This program will provide suggestions for different exercises that can be accessed in widespread locations so traveling will not be a deterrent for participation.  This program will also be open to those who are at elevated risk for developing breast cancer, as exercise and healthy lifestyles can not only reduce the risk of recurrence but also the risk of developing breast cancer. The program expansion will include referrals to a nutritionist, an exercise physiologist and a clinical physiologist as warranted.  Individualized fitness plans and nutritional education sessions will be available via referrals.   Included in this program will be quarterly workshops featuring education on nutrition, physical activity, body image issues and motivation.  We will also provide resources for yoga classes, fitness opportunities in the community, and healthy and nutritious recipes. We will collaborate with HOCC’s Department of Health Promotions for guidance and supervision of the physical activity and nutritional components.