A Study of Blood Pressure Control During Cancer Treatment

PHASE2RecruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

August 18, 2023

Primary Completion Date

December 1, 2027

Study Completion Date

May 30, 2028

Conditions
Breast CancerCardiotoxicity
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

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Rockville Centre

11725

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities), Commack

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER