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NCT Number: NCT06023576

A Study of Blood Pressure Control During Cancer Treatment

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Female assigned at birth
  • Biopsy proven breast cancer (stage I-IV)
  • Treatment with therapy anthracycline-based chemo (with or without HER2-targeted therapy), with >/= 2 cycles of anthracycline chemotherapy planned.
  • SBP ≥130 mm Hg
  • Willing and able to comply with the requirements of the protocol.
  • Participant must have and be willing to use their bluetooth enabled wifi or cellular mobile device
  • (For participants in the CPET cohort): Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria:
  • Achieving a plateau oxygen consumption, concurrent with an increase in power output;
  • A respiratory exchange ratio ≥ 1.10;
  • Attainment of maximal predicted heart rate, as defined by a peak heart rate within 10bpm of the age predicted maximal heart rate (220 - Age[years]);
  • Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.

Exclusion criteria

  • eGFR < 30 ml/min/1.73m2 (based upon Cockcroft-Gault, etc.)
  • Individuals with arm circumference too large to allow accurate BP measurement with available BP devices
  • Inability to accurately measure blood pressure in at least one arm (e.g., bilateral upper extremity lymphedema)
  • Cardiac comorbidity, including any of the following:
  • Acute coronary syndrome within 3 months prior to randomization.
  • Symptomatic heart failure (NYHA class III/IV) within past 6 months
  • History of stroke
  • Cardiac transplantation
  • Other medical disorder or condition that in the opinion of the investigator would impair the subject's ability to participate or adhere to study interventions
  • (For participants in the CPET cohort): Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing:
  • Acute myocardial infarction (within 30 days of any planned study procedures),
  • Unstable angina
  • Uncontrolled arrhythmias causing symptoms or hemodynamic compromise,
  • Symptomatic severe aortic stenosis
  • Recurrent syncope
  • Active endocarditis
  • Acute myocarditis or pericarditis
  • Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures)
  • Thrombosis of lower extremities (within 3 months of any planned study procedures)
  • Suspected dissecting aneurysm
  • Uncontrolled asthma
  • Pulmonary edema
  • Room air desaturation at rest ≤85%
  • Respiratory failure
  • Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
  • Mental impairment leading to inability to cooperate.

Treatment and study plan

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

Primary outcomes

  1. mean change in systolic blood pressure (SBP) from baseline to 12 months

    Time frame: 12 months

    based upon in-office measurement

Study contacts

Contact information is provided by the study sponsor or research team.

Anthony Yu, MD

CONTACT

[email protected]

212-639-7932

Jennifer Liu, MD

CONTACT

212-639-8220

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Sep 5, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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