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RECRUITING
NCT06023576
PHASE2

A Study of Blood Pressure Control During Cancer Treatment

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2023-08-18

Completion Date

2028-05-30

Last Updated

2026-01-02

Healthy Volunteers

No

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

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Centre, New York, United States