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Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent CINV

NCT04437017 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 557

Last updated 2022-07-29

No results posted yet for this study

Summary

Chemotherapy-induced nausea and vomiting is a common side effect of cancer treatments, and dexamethasone offers a clear advantage over placebo for protection against chemotherapy-induced emesis in both acute and delayed phases. However, its side effects such as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort, irritability, increased appetite, weight gain and acne are gathering increasing concerns. Several clinical trials have shown that olanzapine plays an important role in treating delayed, refractory, breakthrough nausea and vomiting. Its side effects mainly include sedation and weight gaining. At present, the NCCN guidelines have recommended olanzapine-containing three-drug regimen for Highly Emetogenic Chemotherapy (HEC) and moderate emetic chemotherapy (MEC) to prevent vomiting, but its data in the Chinese population is limited. Hence, we initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: applying olanzapine to prevent CINV instead of dexamethasone.

Conditions

  • Chemotherapy-induced Nausea and Vomiting

Interventions

DRUG

Olanzapine+NK-1 RA+5-HT3 RA

On day 1-4, Olanzapine (5mg) is delivered orally after dinner.

DRUG

Dexamethasone+NK-1 RA+5-HT3 RA

On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administrated, and on day 2-4, the given dose of dexamethasone is 8 mg.

Sponsors & Collaborators

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Zhigang Liu, M.D. · Fifth Affilliated Hospital of Sun Yat-sen University

  • Zhigang Liu, M.D. · Fifth Affilliated Hospital of Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2022-05-01
Completion
2022-07-01

Countries

  • China

Study Locations

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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 NCT04437017 on ClinicalTrials.gov