Biomarker-Guided Intervention for Chemotherapy Toxicity in Cancer Patients
(NTproBNP-Guide Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byBonnie Ky, MD, MSCE

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Abramson Cancer Center of the University of Pennsylvania

No Placebo Group

Trial Summary

What is the purpose of this trial?

Investigators will evaluate the safety and feasibility of a biomarker-guided cardioprotection strategy using NTproBNP, as compared to usual care, in breast cancer and lymphoma patients treated with anthracyclines.

Research Team

Bonnie Ky, MD, MSCE

Principal Investigator

Perelman School of Medicine at the University of Pennsylvania

Eligibility Criteria

This trial is for adults over 18 with breast cancer or lymphoma who are about to start anthracycline chemotherapy. They must be willing to follow the study plan and not have severe heart, liver, kidney issues, uncontrolled high blood pressure, or be in late-stage cancer. Pregnant or breastfeeding women can't join, and those able to have children must use birth control.

Inclusion Criteria

Provision of written informed consent and HIPAA authorization

I am 18 years old or older.

I am willing and able to follow all study rules and attend all appointments.

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Exclusion Criteria

Non-English speaking

Your average systolic blood pressure is less than 90mmHg in the month before joining the study.

I am not pregnant or breastfeeding and will use effective birth control during the study.

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Treatment Details

Interventions

NTproBNP Guided Strategy of Cardioprotection (Other)

Trial OverviewThe study tests a new way of protecting the heart using NTproBNP biomarker levels to guide treatment during chemotherapy for breast cancer and lymphoma patients compared to standard care without this guidance.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Biomarker Guided ArmExperimental Treatment1 Intervention

NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.

Group II: Usual CareActive Control1 Intervention

NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.