A Study of Blood Pressure Control During Cancer Treatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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
Qualifiers
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.
Disqualifiers
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)
Acute coronary syndrome within 3 months prior to randomization.
Trial design
Treatments tested in this trial
- antihypertensive medications
- Blood pressure measurement
- Echocardiogram
- Symptom-limited cardiopulmonary exercise test
- Quality of Life Measures
- Biomarkers
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov