Status:
TERMINATED
Low Dose Aprepitant for Patients Receiving Carboplatin
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
Jacobi Medical Center
Conditions:
Chemotherapy-induced Nausea and Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study evaluates a simple one day prophylaxis of nausea and vomiting for patients who are getting carboplatin based chemotherapy. In addition to standard oral Dexamethasone and oral Ondansetron, p...
Detailed Description
Main predictive factor for the development of Chemotherapy-induced Nausea and Vomiting (CINV) is the emetic potential of a given chemotherapeutic agent. Carboplatin causes both acute and delayed emesi...
Eligibility Criteria
Inclusion
- No prior chemotherapy
- Confirmed malignancy, scheduled to receive carboplatin monotherapy, or carboplatin in combination with agents of minimal, low, or moderate emetic potential
- Laboratory parameters adequate for chemotherapy
Exclusion
- Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 or 4
- Presence of nausea and vomiting or use of major antiemetic agents during the 24 hours before chemotherapy administration
- Patients receiving radiotherapy within 5 days prior to the carboplatin
- Pregnancy or lactation
- Known allergy to any of the 3 antiemetics
Key Trial Info
Start Date :
October 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03237611
Start Date
October 30 2018
End Date
February 11 2021
Last Update
November 13 2023
Active Locations (2)
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1
Jacobi Medical Center
The Bronx, New York, United States, 10461
2
Montefiore Medical Center
The Bronx, New York, United States, 10461