Cardiometabolic Screening for Breast Cancer Survivors
Recruiting in Palo Alto (17 mi)
Overseen byJennifer Sheng, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Disqualifiers: Metastatic breast cancer
No Placebo Group
Trial Summary
What is the purpose of this trial?This research study is being done to implement a screening program for prediabetes, diabetes, dyslipidemia and/or hyperlipidemia, and higher risk of cardiovascular disease in breast cancer survivors. This program will also help to direct individuals with risk factors to community and institutional resources for management.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment for assessing 10-year cardiovascular risk in breast cancer survivors?
Research shows that breast cancer survivors have a higher risk of developing cardiometabolic issues like diabetes and high cholesterol. This suggests that regular screening and risk assessment can help manage these risks effectively.
12345Is cardiometabolic screening safe for breast cancer survivors?
The studies reviewed do not provide specific safety data for cardiometabolic screening in breast cancer survivors, but they highlight the importance of monitoring cardiometabolic risk factors like obesity, hypertension (high blood pressure), and diabetes, which are common in this group. These factors are associated with increased health risks, suggesting that screening could be beneficial for managing overall health.
16789How does the Cardiometabolic Screening and Enrollment treatment differ from other treatments for breast cancer survivors?
The Cardiometabolic Screening and Enrollment treatment is unique because it focuses on identifying and managing cardiometabolic risk factors, such as high blood pressure, diabetes, and cholesterol issues, in breast cancer survivors, which are not typically addressed by standard cancer treatments. This approach aims to improve long-term health and quality of life by preventing cardiovascular disease, a leading cause of death in these patients.
16101112Eligibility Criteria
This clinical trial is for early-stage breast cancer survivors who have finished their local or systemic therapy at least 3 months ago. Participants must be receiving care through specific Johns Hopkins Medical Institute locations and be able to read and speak English. Those with metastatic breast cancer cannot join.Inclusion Criteria
I am receiving breast cancer treatment at Johns Hopkins or its associated clinics.
I finished my cancer treatment over 3 months ago.
I have been diagnosed with early stage breast cancer.
+1 more
Exclusion Criteria
My breast cancer has spread to other parts of my body.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Cardiometabolic Screening Program
Implementation of a screening program for prediabetes, diabetes, dyslipidemia, and cardiovascular disease risk factors in breast cancer survivors
3 years
Regular visits as per program schedule
Follow-up
Participants are monitored for changes in HbA1c, LDL, weight, and patient-reported outcomes at 6 and 12 months
12 months
Assessments at 6 and 12 months
Referral and Management
Participants with identified risk factors are referred to community and institutional resources for management
Ongoing throughout the study
Participant Groups
The study aims to implement a screening program for conditions like prediabetes, diabetes, dyslipidemia, hyperlipidemia, and increased cardiovascular disease risk in breast cancer survivors. It includes various assessments such as HbA1c levels, lipid panels, BMI evaluations, and cardiovascular risk predictions.
1Treatment groups
Experimental Treatment
Group I: Early stage breast cancer survivorsExperimental Treatment9 Interventions
Patients with history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, MD
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Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
References
Risk of Cardiometabolic Risk Factors in Women With and Without a History of Breast Cancer: The Pathways Heart Study. [2023]The incidence of cardiometabolic risk factors in breast cancer (BC) survivors has not been well described. Thus, we compared risk of hypertension, diabetes, and dyslipidemia in women with and without BC.
Development and validation of a screening instrument to identify cardiometabolic predictors of mortality in older individuals with cancer: Secondary analysis of the Australian Longitudinal Study of Ageing (ALSA). [2019]The objective of this study was to identify significant cardiometabolic predictors of mortality among older cancer survivors and develop and validate a screening instrument to assess individual risk of mortality.
Comorbidities and cardiovascular disease risk in older breast cancer survivors. [2022]To evaluate cardiovascular disease (CVD) risk factors in older breast cancer survivors compared with a group of women without breast cancer.
Temporal patterns of chronic disease incidence after breast cancer: a nationwide population-based cohort study. [2022]We conducted a retrospective cohort study to evaluate the temporal pattern of incidence of chronic conditions after developing breast cancer using a population-based national registry. We selected 84,969 women with newly diagnosed breast cancer between 2002 and 2016 and a 1:10 sample of age-matched non-breast cancer controls (N = 1,057,674). The main study exposure was incident breast cancer, considered as a time-varying exposure. The outcomes were incident cases of leukemia, endometrial cancer, myeloma, cardiomyopathy, osteoporosis, end stage renal disease (ESRD), pulmonary fibrosis, hypothyroidism, type 2 diabetes, hypertension and hyperlipidemia. The development of breast cancer was associated with a significantly increased risk of all outcomes analyzed except for ESRD and hypertension. The fully-adjusted risks of leukemia (HR 3.09; 95% CI 2.11-4.51), cardiomyopathy (HR 2.65; 95% CI 1.90-3.68), endometrial cancer (HR 3.53; 95% CI 2.76-4.53), hypothyroidism (HR 1.29; 95% CI 1.19-1.40), pulmonary fibrosis (HR 1.84; 95% CI 1.12-3.02), and hyperlipidemia (HR 1.24; 95% CI 1.20-1.28) remained significantly elevated after more than 5 years since diagnosis. Optimal care for breast cancer survivors requires close collaboration between oncologists and allied health care professionals to identify and manage the long-term morbidity and mortality associated with these chronic conditions.
[Metabolic syndrome in postmenopausal breast cancer survivors]. [2019]To assess the occurrence of metabolic syndrome (MetS) in postmenopausal breast cancer survivors.
The relation between excess adiposity and breast cancer in women: Clinical implications and management. [2023]Breast cancer (BC) is the most common cancer in women. While the combination of improved screening, earlier detection, and advances in therapeutics has resulted in lower BC mortality, BC survivors are now increasingly dying of cardiovascular disease. Cardiovascular disease in the leading cause of non-cancer related mortality among BC survivors. This situation underscores the critical need to research the role of modifiable cardiometabolic risk factors, such as excess adiposity, that will affect BC remission, long-term survivorship, and overall health and quality of life.
Weight Gain after Hormone Receptor-Positive Breast Cancer. [2022]Obesity following breast cancer diagnosis is associated with poor overall survival. Understanding weight trajectories will help inform breast cancer survivors at greater risk of weight gain, and those who would benefit from earlier anti-obesity interventions. We performed a retrospective chart review of women from the Breast Cancer Program Longitudinal Repository (BCPLR) at Johns Hopkins diagnosed with hormone receptor-positive Stage I-III breast cancer from 2010 to 2020. We investigated obesity (measured by body mass index [BMI]) over time, patient and tumor characteristics, as well as treatment and recurrence. We observed a significant ≥5% increase in BMI from diagnosis to most recent follow-up (p = 0.009), particularly among those who were overweight at diagnosis (p = 0.003). Additionally, among those up to 5 years since diagnosis, there was a significant association between experiencing a ≥0.1 kg/m2 increase per year since diagnosis and baseline BMI status (p = 0.009). A ≥0.6 kg/m2 decrease in BMI was observed for participants with obesity at diagnosis (p = 0.006). Our study highlights (i) the significant burden of obesity in women with a history of breast cancer and (ii) higher risks for increases in BMI and shifts in class of obesity among women who are overweight at diagnosis.
The Living Well after Breast Cancer™ Pilot Trial: a weight loss intervention for women following treatment for breast cancer. [2022]Label="AIM" NlmCategory="OBJECTIVE">Obesity is associated with poor prognosis and risk of treatment side-effects in breast cancer survivors. This pilot study assessed the feasibility, acceptability, safety and efficacy of a telephone-delivered weight loss intervention, among women (BMI 25-40 kg/m2 ) following treatment for stage I-III breast cancer, on weight loss (primary outcome), quality of life and treatment-related side-effects (vs usual care).
Cardiometabolic factors and breast cancer risk in U.S. black women. [2022]Previous studies have suggested that metabolic syndrome may be associated with an increased risk of breast cancer, particularly in postmenopausal women, but U.S. black women have not been assessed. We examined the associations of abdominal obesity, type 2 diabetes, hypertension, and high cholesterol individually and in combination with breast cancer incidence in the Black Women's Health Study. By means of Cox regression models, we estimated incidence rate ratios (IRR) and 95 % confidence intervals (CI) for the associations of baseline and time-dependent values of self-reported abdominal obesity, type 2 diabetes, hypertension, and high cholesterol with breast cancer incidence. During 516,452 person years of follow-up (mean years = 10.5; standard deviation = 2.9) from 1995 to 2007, 1,228 breast cancer cases were identified. After adjustment for age, education, body mass index at age 18, physical activity, and individual cardiometabolic factors, neither individual nor combinations of cardiometabolic factors were associated with breast cancer incidence overall; the multivariable IRR was 1.04 (95 % CI 0.86-1.25) for the combination of ≥3 factors relative to the absence of all factors, and 1.17 (0.85-1.60) for having all four factors. Among postmenopausal women, however, the comparable IRRs were 1.23 (0.93-1.62) and 1.63 (1.12-2.37), respectively. Our findings provide some support for an association between cardiometabolic factors and breast cancer incidence among postmenopausal U.S. black women.
Cardiometabolic risk factors and survival after breast cancer in the Women's Health Initiative. [2021]Few studies have examined the relationship between cardiometabolic risk factors linked to metabolic syndrome and mortality among women with breast cancer.
Cardiometabolic Effects of Endocrine Treatment of Estrogen Receptor-Positive Early Breast Cancer. [2020]Estrogen receptor-positive early breast cancer is common and has a relatively good prognosis. It shares risk factors with cardiovascular disease, and cardiovascular disease is an important competing cause of mortality. Adjuvant endocrine therapy with aromatase inhibitors (requiring concomitant ovarian suppression in premenopausal women) or selective estrogen receptor modulators (usually tamoxifen) exert oncologic benefits by respectively inhibiting estradiol synthesis or breast estrogen receptor signaling. Aromatase inhibitors cause systemic estradiol depletion. Tamoxifen has mixed agonistic/antagonistic effects in a tissue-dependent fashion. Given that estrogens modulate cardiometabolic risk, a review of the effects of endocrine therapy on cardiometabolic outcomes is pertinent. The current, but limited, evidence suggests that tamoxifen treatment, although associated with increases in body fat, hepatic steatosis, serum triglycerides, and diabetes risk, modestly reduces low-density lipoprotein cholesterol and lipoprotein(a) and may have favorable effects on markers of subclinical atherosclerosis. Tamoxifen is associated with either no effect on, or a reduction in, cardiovascular events, and it is associated with an increase in venous thromboembolic events. Aromatase inhibitors, although fewer studies are available and often confounded by comparison with tamoxifen, have not been consistently associated with adverse changes in cardiometabolic risk factors or increases in cardiovascular events. Further clinical trials designed to evaluate cardiometabolic outcomes are needed to more accurately determine the effects of endocrine therapy on cardiovascular risks, to inform individualized decisions regarding choice and duration of endocrine therapy, and to implement evidence-based strategies to mitigate cardiometabolic risks. In the meantime, although breast cancer-specific evidence for benefit of lifestyle measures is available and recommended routinely, proactive monitoring and treatment of cardiovascular risk factors should follow general population recommendations.
Changes in metabolic risk, insulin resistance, leptin and adiponectin following a lifestyle intervention in overweight and obese breast cancer survivors. [2019]Adiposity and physical activity are modifiable factors that could be important determinants of breast cancer (BC) prognosis through their effects on endogenous reproductive hormones, chronic inflammation and metabolic changes. Therefore, it is necessary to evaluate whether offering lifestyle interventions to BC survivors could affect the levels of certain biomarkers involved in these mechanisms. We designed a pre-post intervention study offering diet and exercise sessions over 12 weeks to 42 overweight/obese BC survivors. Before and after the intervention, we obtained dietary information, anthropometry and cardiorespiratory fitness (CRF) measurements and blood samples to measure metabolic risk, insulin resistance and adipokines biomarkers. Wilcoxon signed-rank tests and Spearman partial correlation coefficients were used to compare pre- and post-measurements and assess the correlations between changes in biomarkers and changes in anthropometry and CRF. Breast cancer survivors showed significant improvements in metabolic risk biomarkers and insulin resistance indicators along with a non-significant leptin decrease and a significant adiponectin decrease. The improvements in metabolic risk biomarkers, insulin resistance indicators and leptin were moderately correlated (0.32 ≤ |r| ≤ 0.55) with the decrease in body mass index and the increase in CRF. Diet and exercise interventions implemented in overweight/obese BC survivors may improve metabolic risk, insulin resistance and leptin biomarkers.