A Study of Blood Pressure Control During Cancer Treatment
Breast Cancer, Cardiotoxicity
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Blood pressure, 23-159
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Female assigned at birth Biopsy proven breast cancer (stage I-IV) Planned treatment with cardiotoxic cancer therapy (e.g., anthracycline chemotherapy, with or without HER2-targeted therapy) SBP ≥130 mm Hg Willing and able to comply with the requirements of the protocol. Participant must have and be willing to use their bluetooth enabled wifi or cellular mobile device (For participants in the CPET cohort): Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria: Achieving a plateau oxygen consumption, concurrent with an increase in power output; A respiratory exchange ratio ≥ 1.10; Attainment of maximal predicted heart rate, as defined by a peak heart rate within 10bpm of the age predicted maximal heart rate (220 - Age[years]); Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale. Exclusion Criteria: eGFR < 30 ml/min/1.73m2 (based upon Cockcroft-Gault, etc.) Individuals with arm circumference too large to allow accurate BP measurement with available BP devices Inability to accurately measure blood pressure in at least one arm (e.g., bilateral upper extremity lymphedema) Cardiac comorbidity, including any of the following: Acute coronary syndrome within 3 months prior to randomization. Symptomatic heart failure (NYHA class III/IV) within past 6 months History of stroke Cardiac transplantation Other medical disorder or condition that in the opinion of the investigator would impair the subject's ability to participate or adhere to study interventions (For participants in the CPET cohort): Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing: Acute myocardial infarction (within 30 days of any planned study procedures), Unstable angina Uncontrolled arrhythmias causing symptoms or hemodynamic compromise, Symptomatic severe aortic stenosis Recurrent syncope Active endocarditis Acute myocarditis or pericarditis Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures) Thrombosis of lower extremities (within 3 months of any planned study procedures) Suspected dissecting aneurysm Uncontrolled asthma Pulmonary edema Room air desaturation at rest ≤85% Respiratory failure Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) Mental impairment leading to inability to cooperate.
Sites / Locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
standard-of-care antihypertensive medications
higher dose antihypertensive medications
This will consist of treatment with antihypertensive medications titrated every 4 weeks for the first 3 months, and then every 3 months in months 4-12. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.
Patients randomized to intensive SBP control will be treated to achieve an SBP goal <120 mm Hg, and patients randomized to standard SBP control will be treated to achieve an SBP goal <140 mm Hg. Antihypertensive medications will be titrated on the basis of seated blood pressure measurements obtained after a 5-min rest period. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.