A Study of Blood Pressure Control During Cancer Treatment
Phase 2
Recruiting
- Conditions
- Breast CancerCardiotoxicity
- Interventions
- Other: antihypertensive medicationsDiagnostic Test: Blood pressure measurementDiagnostic Test: EchocardiogramOther: Symptom-limited cardiopulmonary exercise testOther: Quality of Life MeasuresDiagnostic Test: Biomarkers
- Registration Number
- NCT06023576
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
The purpose of this study to find out whether an intensive approach to treating high blood pressure during breast cancer treatment is safe and more effective than standard blood pressure treatment at lowering blood pressure levels and the risk of cardiotoxicity in patients with cancer. Other studies have shown lowering blood pressure improves the health of patients. However, these studies have not included people with cancer.
The PROTECT trial is testing a treatment strategy regarding intensive versus standard SBP goals, and is not testing specific medications.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 130
Inclusion Criteria
-
Age ≥ 18 years
-
Female assigned at birth
-
Biopsy proven breast cancer (stage I-IV)
-
Treatment with therapy anthracycline-based chemo (with or without HER2-targeted therapy), with >/= 2 cycles of anthracycline chemotherapy planned.
-
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.)
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard-of-care antihypertensive medications antihypertensive medications SBP control 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. SBP control will be achieved by titration of antihypertensive medications based upon a standardized algorithm and will be implemented during a 12-month study period. At the time of randomization, no antihypertensive treatments may be initiated or modified if SBP is ≥160 mm Hg. The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider. higher dose antihypertensive medications antihypertensive medications 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.The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider. standard-of-care antihypertensive medications Echocardiogram SBP control 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. SBP control will be achieved by titration of antihypertensive medications based upon a standardized algorithm and will be implemented during a 12-month study period. At the time of randomization, no antihypertensive treatments may be initiated or modified if SBP is ≥160 mm Hg. The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider. higher dose antihypertensive medications Quality of Life Measures 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.The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider. standard-of-care antihypertensive medications Blood pressure measurement SBP control 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. SBP control will be achieved by titration of antihypertensive medications based upon a standardized algorithm and will be implemented during a 12-month study period. At the time of randomization, no antihypertensive treatments may be initiated or modified if SBP is ≥160 mm Hg. The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider. standard-of-care antihypertensive medications Symptom-limited cardiopulmonary exercise test SBP control 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. SBP control will be achieved by titration of antihypertensive medications based upon a standardized algorithm and will be implemented during a 12-month study period. At the time of randomization, no antihypertensive treatments may be initiated or modified if SBP is ≥160 mm Hg. The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider. standard-of-care antihypertensive medications Biomarkers SBP control 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. SBP control will be achieved by titration of antihypertensive medications based upon a standardized algorithm and will be implemented during a 12-month study period. At the time of randomization, no antihypertensive treatments may be initiated or modified if SBP is ≥160 mm Hg. The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider. standard-of-care antihypertensive medications Quality of Life Measures SBP control 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. SBP control will be achieved by titration of antihypertensive medications based upon a standardized algorithm and will be implemented during a 12-month study period. At the time of randomization, no antihypertensive treatments may be initiated or modified if SBP is ≥160 mm Hg. The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider. higher dose antihypertensive medications Symptom-limited cardiopulmonary exercise test 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.The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider. higher dose antihypertensive medications Echocardiogram 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.The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider. higher dose antihypertensive medications Blood pressure measurement 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.The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider. higher dose antihypertensive medications Biomarkers 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.The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider.
- Primary Outcome Measures
Name Time Method mean change in systolic blood pressure (SBP) from baseline to 12 months 12 months based upon in-office measurement
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
🇺🇸Rockville Centre, New York, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
🇺🇸New York, New York, United States