A Study of Blood Pressure Control During Cancer Treatment

Official title

Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial

Overview

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.

Interventions

• Other antihypertensive medications
  One or more of the following medications may be used in both randomization groups to achieve SBP goals: * Angiotensin converting enzyme inhibitors (ACEI) * Angiotensin receptor blockers (ARBs) * Beta-blockers (BB) * Thiazide-type diuretics * Calcium channel blockers * Aldosterone antagonists * Alpha1-receptor blockers. * Direct vasodilators * Loop diuretics
• Diagnostic test Blood pressure measurement
  Home BP Monitoring (HBPM)-Throughout the study period, patients will perform HBPM at baseline, month 6, and month 12 (end of treatment). At each of these timepoints, HBPM will be performed for 7 days with 2 morning and 2 evening readings for each day (measured 1-min part).
• Diagnostic test Echocardiogram
  At baseline, month 6, and month 12
• Other Symptom-limited cardiopulmonary exercise test
  Consecutive patients in each treatment group who meet the eligibility criteria for exercise testing will be offered to participate in CPET at the time of consent. Patients who agree will undergo CPET (baseline, 6 months, and 12 months) until the target accrual of 33 patients per group is met.
• Other Quality of Life Measures
  FACT-B, Fatigue Symptom Inventory (FSI), Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, Godin Leisure Time Exercise Questionnaire (GLTEQ),PROMIS Medication Adherence Scale. Given baseline, 3 months and 12 months.
• Diagnostic test Biomarkers
  Research blood samples will be collected at baseline, 3 months, and 6 months

Primary outcome measures

• mean change in systolic blood pressure (SBP) from baseline to 12 months [Time frame: 12 months]

Eligibility criteria

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.)
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 7 centers

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Rockville Centre

Identifiers

NCT: NCT06023576 · 23-159

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗