RecruitingPhase 2NCT06023576

A Study of Blood Pressure Control During Cancer Treatment

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

130 participants

Start Date

Aug 18, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Cardiotoxicity

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether controlling high blood pressure during chemotherapy can protect the heart in women being treated for breast cancer. Certain chemotherapy drugs (anthracyclines) can harm heart function, especially when blood pressure is elevated. Participants will use a smartphone app to monitor their blood pressure at home. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with breast cancer (any stage) - You are scheduled to receive at least 2 cycles of anthracycline-based chemotherapy - Your systolic blood pressure is 130 mmHg or higher - You have a Bluetooth-enabled smartphone **You may NOT be eligible if...** - Your kidneys are not functioning well (low eGFR) - You cannot have blood pressure measured accurately in either arm - You have had a heart attack in the last 3 months, severe heart failure, or a history of stroke - You have an unstable heart condition such as uncontrolled arrhythmia or severe aortic stenosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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