A Study of Blood Pressure Control During Cancer Treatment

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06023576
• Other study ID #: 23-159
• Status: Recruiting
• Phase: Phase 2
• Start date: August 18, 2023
• Est. completion date: May 30, 2028

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Anthony Yu, MD
• Phone: 212-639-7932
• Email: yua3[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: May 30, 2028
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiotoxicity

Intervention

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).
• 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.
• 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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean change in systolic blood pressure (SBP) from baseline to 12 months	based upon in-office measurement	12 months

External Links

•   Memorial Sloan Kettering Cancer Center