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Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens

NCT02635984 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2018-08-20

Study results available
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Summary

The objective of this study is to compare the effectiveness of olanzapine added to standard triplet therapy (fosaprepitant, ondansetron, and dexamethasone) versus triplet therapy alone in preventing chemotherapy-induced nausea and vomiting (CINV) in hematology patients receiving highly or moderately emetogenic chemotherapy regimens.

Conditions

  • Complications of Bone Marrow Transplant
  • Hematologic Neoplasms

Interventions

DRUG

Olanzapine

Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

DRUG

Placebo

Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

Sponsors & Collaborators

  • University of Georgia

    collaborator OTHER

  • Augusta University

    lead OTHER

Principal Investigators

  • Amber B Clemmons, PharmD · Augusta University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-12-31
Completion
2017-12-31

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 NCT02635984 on ClinicalTrials.gov