A Study of Blood Pressure Control During Cancer Treatment
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: standard-of-care antihypertensive medications 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. |
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).
Diagnostic Test: 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.
Other: 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
|
| Experimental: higher dose antihypertensive medications 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. |
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).
Diagnostic Test: 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.
Other: 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
|
Outcome Measures
Primary Outcome Measures
- mean change in systolic blood pressure (SBP) from baseline to 12 months [12 months]
based upon in-office measurement
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey | United States | 07920 |
| 2 | Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey | United States | 07748 |
| 3 | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey | United States | 07645 |
| 4 | Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | Commack | New York | United States | 11725 |
| 5 | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York | United States | 10604 |
| 6 | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | United States | 10065 |
| 7 | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Rockville Centre | New York | United States | 11553 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Anthony Yu, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 23-159