Status:
TERMINATED
Prevention of Anthracycline or Trastuzumab Induced Cardiomyopathy by Metoprolol
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to investigate whether giving prophylactic metoprolol prior to and during anthracycline or trastuzumab therapy will decrease the incidence of anthracycline-induc...
Detailed Description
This is a randomized, controlled exploration. Consent will be obtained from patients receiving care for cancer with anthracycline or trastuzumab at the University Of Maryland Greenebaum Cancer Center ...
Eligibility Criteria
Inclusion
- Patients must have confirmed malignancy for which standard regimens of anthracyclines or trastuzumab are being offered as treatment at the University of Maryland Greenebaum Cancer Center. Patients must either receive 4 cycles of anthracycline for a total dose of 240 mg/m2 or six cycles of TAC for a total dose of 300 mg/m2 or trastuzumab.
- Age \> 18 years
- Ability to understand and willingness to sign a written informed consent document.
- Women of childbearing potential may participate in this study only if they have a negative pregnancy test and agree not to become pregnant during the study. Woman of childbearing potential must use an effective method of birth control such as hormonal contraceptives (oral and implant) condoms, diaphragms, spermicidal foam or jelly, surgical (hysterectomy or tubal ligation) or intrauterine device.
Exclusion
- Patients who have established dilated or restrictive cardiomyopathy with EF \< 40 %.
- Patients with severe mitral or aortic valve disease (valve area \<1cm squared).
- Patients who have any contraindication to metoprolol, in particular bradycardia with HR \< 50, or severe reactive pulmonary disease such as asthma. Patients who take mibefradil or psychiatric drugs (such as phenothiazines including chlorpromazine and thioridazine) will also be excluded from the study as they have serious interactions with beta-blockers
- Patients who have untreated thyroid function disorder.
- Pregnant and nursing women are excluded from this study because of potential risk for adverse events to the fetus.
- Patients with any impediment to swallowing tablets would be excluded.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00806390
Start Date
July 1 2008
End Date
June 1 2012
Last Update
February 25 2022
Active Locations (1)
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1
University of Maryland
Baltimore, Maryland, United States, 21201