Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial
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.
Arms & interventions
- Otherantihypertensive 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 TestBlood 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 TestEchocardiogram
At baseline, month 6, and month 12
- OtherSymptom-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.
- OtherQuality 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 TestBiomarkers
Research blood samples will be collected at baseline, 3 months, and 6 months
Outcome measures
Primary
mean change in systolic blood pressure (SBP) from baseline to 12 months
based upon in-office measurement
Time frame: 12 months
Eligibility criteria
Study locations (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, 11553