search
Back to results

A Study of Blood Pressure Control During Cancer Treatment

Primary Purpose

Breast Cancer, Cardiotoxicity

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
antihypertensive medications
Blood pressure measurement
Echocardiogram
Symptom-limited cardiopulmonary exercise test
Quality of Life Measures
Biomarkers
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Blood pressure, 23-159

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years Female assigned at birth Biopsy proven breast cancer (stage I-IV) Planned treatment with cardiotoxic cancer therapy (e.g., anthracycline chemotherapy, with or without HER2-targeted therapy) 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.

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

standard-of-care antihypertensive medications

higher dose antihypertensive medications

Arm Description

This will consist of treatment with antihypertensive medications titrated every 4 weeks for the first 3 months, and then every 3 months in months 4-12. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.

Patients randomized to intensive SBP control will be treated to achieve an SBP goal <120 mm Hg, and patients randomized to standard SBP control will be treated to achieve an SBP goal <140 mm Hg. Antihypertensive medications will be titrated on the basis of seated blood pressure measurements obtained after a 5-min rest period. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.

Outcomes

Primary Outcome Measures

mean change in systolic blood pressure (SBP) from baseline to 12 months
based upon in-office measurement

Secondary Outcome Measures

Full Information

First Posted
August 18, 2023
Last Updated
August 29, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT06023576
Brief Title
A Study of Blood Pressure Control During Cancer Treatment
Official Title
Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
August 18, 2027 (Anticipated)
Study Completion Date
August 18, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cardiotoxicity
Keywords
Blood pressure, 23-159

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This open-label, two-arm RCT will compare the effects of intensive versus standard SBP control in patients with BC and HTN receiving anthracycline-based treatment (with or without HER2-targeted therapy).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard-of-care antihypertensive medications
Arm Type
Experimental
Arm Description
This will consist of treatment with antihypertensive medications titrated every 4 weeks for the first 3 months, and then every 3 months in months 4-12. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.
Arm Title
higher dose antihypertensive medications
Arm Type
Experimental
Arm Description
Patients randomized to intensive SBP control will be treated to achieve an SBP goal <120 mm Hg, and patients randomized to standard SBP control will be treated to achieve an SBP goal <140 mm Hg. Antihypertensive medications will be titrated on the basis of seated blood pressure measurements obtained after a 5-min rest period. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.
Intervention Type
Other
Intervention Name(s)
antihypertensive medications
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood pressure measurement
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Echocardiogram
Intervention Description
At baseline, month 6, and month 12
Intervention Type
Other
Intervention Name(s)
Symptom-limited cardiopulmonary exercise test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Quality of Life Measures
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Biomarkers
Intervention Description
Research blood samples will be collected at baseline, 3 months, and 6 months
Primary Outcome Measure Information:
Title
mean change in systolic blood pressure (SBP) from baseline to 12 months
Description
based upon in-office measurement
Time Frame
12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female assigned at birth
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Female assigned at birth Biopsy proven breast cancer (stage I-IV) Planned treatment with cardiotoxic cancer therapy (e.g., anthracycline chemotherapy, with or without HER2-targeted therapy) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Yu, MD
Phone
212-639-7932
Email
yua3@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Liu, MD
Phone
212-639-8220
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Yu, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Yu, MD
Phone
212-639-7932
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Yu, MD
Phone
212-639-7932
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Yu, MD
Phone
212-639-7932
Facility Name
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Yu, MD
Phone
212-639-7932
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Yu, MD
Phone
212-639-7932
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Yu, MD
Phone
212-639-7932
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Yu, MD
Phone
212-639-7932

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

A Study of Blood Pressure Control During Cancer Treatment

We'll reach out to this number within 24 hrs