Clinical trial NCT06023576: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Cardiotoxicity
Keywords: Blood pressure
23-159
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: mean change in systolic blood pressure (SBP) from baseline to 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Anthony Yu, MD
role: PRINCIPAL_INVESTIGATOR
References: