RECRUITING

A Study of Blood Pressure Control During Cancer Treatment

Conditions

Breast Cancer Cardiotoxicity Blood pressure 23-159

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-08-18

Study Completion:2028-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06023576

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Anthony Yu, MD

CONTACT

212-639-7932

yua3@mskcc.org

Jennifer Liu, MD

CONTACT

212-639-8220

Principal Investigator

Anthony Yu, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Centre, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Anthony Yu, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-18

Study Completion Date2028-05-30

Study Record Updates

Study Start Date2023-08-18

Study Completion Date2028-05-30

Terms related to this study

Keywords Provided by Researchers

Blood pressure
23-159

Additional Relevant MeSH Terms

Breast Cancer
Cardiotoxicity