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Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy
NCT03578081 · View on ClinicalTrials.gov ↗
Study Summary
This randomized phase III trial studies how well olanzapine with or without fosaprepitant work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control nausea and vomiting in patients during chemotherapy. Olanzapine is usually given in combination with other drugs, including fosaprepitant dimeglumine. It is not yet known if olanzapine when given with other drugs, is still effective without using fosaprepitant dimeglumine for controlling nausea and vomiting.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Olanzapine
- DRUG Palonosetron Hydrochloride
- DRUG Ondansetron Hydrochloride
- DRUG Fosaprepitant Dimeglumine
Study Locations (20)
California
- PCR Oncology — Arroyo Grande
- Epic Care-Dublin — Dublin
- Bay Area Breast Surgeons Inc — Emeryville
- Epic Care Partners in Cancer Care — Emeryville
- Tibor Rubin VA Medical Center — Long Beach
- Contra Costa Regional Medical Center — Martinez
- Alta Bates Summit Medical Center - Summit Campus — Oakland
- Bay Area Tumor Institute — Oakland
- Desert Regional Medical Center — Palm Springs
- Epic Care Cyberknife Center — Walnut Creek
Arizona
- Kingman Regional Medical Center — Kingman
- Mayo Clinic Hospital in Arizona — Phoenix
- Mayo Clinic in Arizona — Scottsdale
Colorado
- Rocky Mountain Cancer Centers-Aurora — Aurora
- The Medical Center of Aurora — Aurora
- Boulder Community Hospital — Boulder
Arkansas
- Mercy Hospital Fort Smith — Fort Smith
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
Alaska
- Fairbanks Memorial Hospital — Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 690 participants |
| Start Date | 2018-11-20 |
| Est. Completion | 2023-05-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03578081
The ClinicalTrials.gov registry entry for NCT03578081 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 690 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Malignant Neoplasm appearing as the primary indexed condition, and to 5 interventions — of which Dexamethasone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03578081 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03578081 about?
NCT03578081 is a clinical study titled "Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy". This randomized phase III trial studies how well olanzapine with or without fosaprepitant work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control nausea and vomiting in patie...
What is the current status of trial NCT03578081?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 690 participants. The study started on 2018-11-20. Estimated completion is 2023-05-01.
What conditions does trial NCT03578081 study?
This clinical trial studies the following conditions: Malignant Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03578081?
The interventions under investigation include: Dexamethasone (DRUG), Olanzapine (DRUG), Palonosetron Hydrochloride (DRUG), Ondansetron Hydrochloride (DRUG), Fosaprepitant Dimeglumine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03578081?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03578081 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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