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RecruitingPhase 2

A Study of Blood Pressure Control During Cancer Treatment

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares a lower blood pressure goal with a standard goal during breast cancer treatment. It checks whether the lower goal is safe and better at lowering blood pressure and the risk of heart damage. It is for adults assigned female at birth who have breast cancer and high blood pressure, and tests blood pressure goals, not specific medicines.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older and assigned female at birth.
  • Have stage I–IV breast cancer confirmed by a biopsy (a tissue sample).
  • Receive anthracycline chemotherapy, with at least 2 cycles planned. Treatment targeting HER2, a protein on some cancer cells, is also allowed.
  • Have a top blood pressure number of 130 mm Hg or higher.
  • Be willing and able to follow the study rules.
  • Have and be willing to use a mobile device with Bluetooth and Wi-Fi or cellular service.
  • For the exercise-test group: complete a starting heart and lung exercise test that meets the study's effort goals, without unsafe heart signals or other unsafe responses, as judged by the study doctor.

Who can't join

  • Have severely reduced kidney function, with a kidney filtering score below 30.
  • Have arms too large for the study's blood pressure cuffs, or no arm where blood pressure can be measured accurately.
  • Have had a sudden heart blood-flow problem within 3 months, severe heart failure symptoms within 6 months, a stroke, or a heart transplant.
  • Have another condition that the study doctor thinks would prevent participation or following study treatments.
  • For the exercise-test group: have had a heart attack within 30 days of study procedures; unstable chest pain; an uncontrolled, harmful heart rhythm; severe narrowing of the aortic heart valve with symptoms; or repeated fainting.
  • For the exercise-test group: have an active heart infection or sudden inflammation of the heart or its lining; suspected tearing of a bulging artery; or a lung or leg blood clot within 3 months of study procedures.
  • For the exercise-test group: have uncontrolled asthma, fluid in the lungs, oxygen levels of 85% or less at rest without added oxygen, or lungs that cannot provide enough oxygen.
  • For the exercise-test group: have another sudden illness that could affect or worsen with exercise, or problems with thinking that prevent cooperation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (7)

NJ

NY