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Low Dose Aprepitant for Patients Receiving Carboplatin

NCT03237611 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-11-13

Study results available
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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, participants will be given a third neurokinin 1 (NK1) antagonist agent, either a single dose of oral Aprepitant or intravenous (IV) Fosaprepitant (they have been shown to be equally effective) to improve prevention of nausea and vomiting. No medications need to be taken beyond day 1.

Conditions

  • Chemotherapy-induced Nausea and Vomiting

Interventions

DRUG

Aprepitant 125 mg

Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting

DRUG

Fosaprepitant 115 MG

Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting

DRUG

Dexamethasone

Dexamethasone will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 20mg on day 1 of chemotherapy

DRUG

Ondansetron 16 MG

Ondansetron will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 16mg on day 1 of chemotherapy

Sponsors & Collaborators

  • Jacobi Medical Center

    collaborator OTHER

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Richard Gralla, MD · Albert Einstein College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-30
Primary Completion
2021-02-11
Completion
2021-02-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03237611 on ClinicalTrials.gov