A Study of Blood Pressure Control During Cancer Treatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Acute coronary syndrome within 3 months prior to randomization.
Trial design
Design model
Parallel
Treatments tested in this trial
antihypertensive medications
Other interventionOne 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
Blood pressure measurement
Diagnostic testHome 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).
Echocardiogram
Diagnostic testAt baseline, month 6, and month 12
Symptom-limited cardiopulmonary exercise test
Other interventionConsecutive 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.
Quality of Life Measures
Other interventionFACT-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.
Biomarkers
Diagnostic testResearch blood samples will be collected at baseline, 3 months, and 6 months
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: standard-of-care antihypertensive medicationsExperimental treatment 6 interventions
Group B: higher dose antihypertensive medicationsExperimental treatment 6 interventions
Trial outcomes
Primary outcomes
1
mean change in systolic blood pressure (SBP) from baseline to 12 months
based upon in-office measurement
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov