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New treatment option for Breast Cancer
Official title A Study of Blood Pressure Control During Cancer Treatment
ClinicalTrials.gov ID: NCT06023576
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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.
- 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): people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.