A Study of Blood Pressure Control During Cancer Treatment

Conditions

• Breast Cancer
• Cardiotoxicity

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• antihypertensive medications — OTHER
  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
• Blood pressure measurement — DIAGNOSTIC_TEST
  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).
• Echocardiogram — DIAGNOSTIC_TEST
  At baseline, month 6, and month 12
• Symptom-limited cardiopulmonary exercise test — OTHER
  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.
• Quality of Life Measures — OTHER
  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.
• Biomarkers — DIAGNOSTIC_TEST
  Research blood samples will be collected at baseline, 3 months, and 6 months

Study Details

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.

Key Dates

Start date

Aug 18, 2023

Status verified

May 2026

Primary completion

Dec 1, 2028

Completion

May 30, 2029

Study Design

Enrollment

130 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: standard-of-care 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.
• Experimental: higher dose 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.

Primary Outcome Measure

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

Central Contacts

• Anthony Yu, MD
  212-639-7932
  [email protected]
• Jennifer Liu, MD
  212-639-8220

Locations (7)

Find similar trials in Basking Ridge, NJ

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