Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 24-009445
Sponsor Protocol Number: 24-009445
About this study
The goal of this pilot study is to demonstrate that obesity is associated with worse reactive hyperemic index, a marker of vascular function, in breast cancer survivors. For this, we propose to measure and compare reactive hyperemic index in breast cancer survivors with and without obesity.
Background
Cardiovascular disease (CVD) is the leading cause of death in women, accounting for 35% of female deaths. While in the past five decades, the 5-year breast cancer (BC)-specific mortality decreased from 25% to 9%, BC survivors are dying of CVD at unprecedented rates. Compared to women who have never had cancer, postmenopausal BC survivors have a 1.5- to 2-fold greater risk of CVD mortality. This is at least partly due to the fact that some BC treatments that are critical for survival confer a higher CVD risk, and also partly due to common CVD risk factors, such as obesity. In BC survivors, obesity increases CVD risk mortality by 2.5-fold. Estimates suggest that by 2050, >60% of US adult women will be living with obesity. With a rapidly growing number of BC survivors, projected to increase from four to five million over the next decade in the US, obesity represents a target to reduce their CVD risk.
Endothelial vascular dysfunction, referred here on as vascular function, is a preclinical marker of CVD and a strong predictor of CVD mortality. Obesity is independently associated with vascular dysfunction, a result of adipokine-mediated inflammation in obesity [6]. Vascular dysfunction is also reported with anticancer treatments in BC survivors. Aromatase inhibitors (AIs), a common therapy for postmenopausal BC, for example have been linked to vascular dysfunction, via decreased levels of estrogens that are critical for CV health in women. While obesity in BC survivors may synergistically impact vascular dysfunction, no studies to date have investigated this.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Recently postmenopausal breast cancer survivors (menopause defined as menopause defined as the natural/spontaneous cessation of menses for at least 12 months and recently menopausal women as women between 1 and 3 years of their final menstrual cycle).
- History of breast cancer diagnosed within the past wo years.
- Aged 46-55 years of age.
- For participants with obesity, a BMI ≥ 30 kg/m2 at the time of breast cancer diagnosis.
- For participants without obesity, a BMI < 25 kg/m2 at the time of breast cancer diagnosis.
Exclusion Criteria:
- History of Radiation Therapy for breast cancer.
- chaiChanges in weight of more than 5% from the weight at breast cancer diagnosis.
- Early menopause (menopause occurring before age 45).
- History of surgical menopause.
- Current or previous treatment with menopausal hormone therapy.
- History of established cardiovascular disease, including coronary atherosclerosis, ischemic heart disease, peripheral vascular disease, or stroke.
- Statin Use.
- 10-year ASCVD risk <5%.
- History of smoking.
- History of type 1 or 2 diabetes.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 9/4/2024. Questions regarding updates should be directed to the study team contact.