Pilot Study of an NTproBNP Guided Strategy of Cardioprotection (NCT04737265) | Clinical Trial Compass
CompletedPhase 1/2
Pilot Study of an NTproBNP Guided Strategy of Cardioprotection
United States101 participantsStarted 2021-03-18
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Provision of written informed consent and HIPAA authorization
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, ≥ 18 years of age
* Diagnosed with breast cancer or lymphoma (any subtype), planned to receive an anthracycline based chemotherapy regimen. Patients may be enrolled up to their first dose of anthracycline even if they have already received other chemotherapeutic or targeted agents as part of neo-adjuvant or adjuvant systemic therapy.
Exclusion Criteria:
* Diagnosed with Stage IV breast cancer
* Uncontrolled blood pressure defined by SBP \> 180mmHg on two or more occasions and taking three or more antihypertensives within 1 month prior to enrollment.
* Baseline systolic blood pressure \< 90mmHg within 1 month prior to enrollment (if multiple blood pressures are available in the medical record within 1 month prior to enrollment, the average SBP will be considered)
* Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with some anti-hypertensives, including angiotensin receptor blockers. All females of childbearing potential must have a blood test or urine study within 10 days prior to enrollment to rule out pregnancy. All females of childbearing potential must be strongly advised to use accepted and effective methods of contraception or to abstain from sexual intercourse for the d…
What they're measuring
1
Recruitment Rate
Timeframe: At baseline
2
Retention rate
Timeframe: Through study completion (expected to be 1 year)
3
Adherence rate
Timeframe: Through study completion (expected to be 1 year)
4
Compliance rate
Timeframe: Through study completion (expected to be 1 year)
5
Maximum tolerated dose
Timeframe: Through study completion (expected to be 1 year)