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Intensive Blood Pressure Control for Cardiotoxicity in Cancer Patients

Q: What evidence is there to support the safety of mainstream hypertension treatments?

As standard-of-care antihypertensive medications are presently in Phase 2 trials, there is limited evidence to suggest their safety and efficacy. Thus, our team has assigned them a score of 2 on the 1-3 scale.

Q: What are the geographic locales where this clinical trial is being conducted?

Presently, this clinical trial is running in 7 distinct locations. In addition to Middletown, Montvale and Commack, other cities are hosting the study; thus it's paramount that you select the center nearest your residence to reduce travel strains if you join.

Q: How many individuals have committed to participating in this research trial?

Exactly. According to the details on clinicaltrials.gov, this research is currently recruiting members from a total of 7 sites for an approximate 130 participants. The trial began recruitment on August 18th 2023 and was most recently updated on August 29th that same year.

Q: Are additional participants being considered for this trial?

Affirmative. The information available on clinicaltrials.gov confirms that, since its inception on August 18th 2023, this research project is recruiting 130 participants from seven sites across the United States of America.

Phase 2

Recruiting

Led By Anthony Yu, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned treatment with cardiotoxic cancer therapy (e.g., anthracycline chemotherapy, with or without HER2-targeted therapy)

Biopsy proven breast cancer (stage I-IV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial aims to find if intensively lowering blood pressure safely helps cancer patients reduce risk of heart issues.

Who is the study for?

This trial is for women diagnosed with breast cancer (stages I-IV) who are about to undergo treatment that could harm the heart and have high blood pressure (≥130 mm Hg). They must be able to follow the study's rules, use a Bluetooth-enabled mobile device, and if participating in exercise testing, complete a baseline test without certain heart risks. Excluded are those with severe kidney issues, measurement difficulties due to arm size or lymphedema, recent serious heart problems or stroke.Check my eligibility

What is being tested?

The PROTECT trial is examining whether intensively treating high blood pressure during breast cancer therapy can better lower blood pressure and reduce heart damage risk compared to standard treatment. It's not testing specific drugs but rather strategies for setting systolic blood pressure goals.See study design

What are the potential side effects?

While this study isn't testing specific medications, potential side effects may include typical reactions related to antihypertensive drugs such as dizziness, fatigue, headaches or more rarely severe drops in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for cancer treatment that may affect my heart.

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My breast cancer diagnosis was confirmed through a biopsy.

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I was assigned female at birth.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

mean change in systolic blood pressure (SBP) from baseline to 12 months

Trial Design

2Treatment groups

Experimental Treatment

Group I: standard-of-care antihypertensive medicationsExperimental Treatment6 Interventions

SBP control 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. SBP control will be achieved by titration of antihypertensive medications based upon a standardized algorithm and will be implemented during a 12-month study period. At the time of randomization, no antihypertensive treatments may be initiated or modified if SBP is ≥160 mm Hg. The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider.

Group II: higher dose antihypertensive medicationsExperimental Treatment6 Interventions

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.The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biomarkers

2018

N/A

~100

Blood pressure measurement

2019

N/A

~360

Echocardiogram

2016

Completed Phase 2

~1870

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,768 Total Patients Enrolled

202 Trials studying Breast Cancer

80,973 Patients Enrolled for Breast Cancer

Anthony Yu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

4 Previous Clinical Trials

364 Total Patients Enrolled

3 Trials studying Breast Cancer

306 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What evidence is there to support the safety of mainstream hypertension treatments?

"As standard-of-care antihypertensive medications are presently in Phase 2 trials, there is limited evidence to suggest their safety and efficacy. Thus, our team has assigned them a score of 2 on the 1-3 scale."

Answered by AI

What are the geographic locales where this clinical trial is being conducted?

"Presently, this clinical trial is running in 7 distinct locations. In addition to Middletown, Montvale and Commack, other cities are hosting the study; thus it's paramount that you select the center nearest your residence to reduce travel strains if you join."

Answered by AI

How many individuals have committed to participating in this research trial?

"Exactly. According to the details on clinicaltrials.gov, this research is currently recruiting members from a total of 7 sites for an approximate 130 participants. The trial began recruitment on August 18th 2023 and was most recently updated on August 29th that same year."

Answered by AI

Are additional participants being considered for this trial?

"Affirmative. The information available on clinicaltrials.gov confirms that, since its inception on August 18th 2023, this research project is recruiting 130 participants from seven sites across the United States of America."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Blood Pressure Control During Cancer Treatment

2023. "A Study of Blood Pressure Control During Cancer Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06023576.