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

  • STATUS
    Recruiting
  • End date
    Feb 3, 2022
  • participants needed
    548
  • sponsor
    Fifth Affiliated Hospital, Sun Yat-Sen University
Updated on 22 February 2021
nausea
cancer
dexamethasone
hyperglycemia
gemcitabine
olanzapine
emetic

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.

Details
Condition Chemotherapy-induced Nausea and Vomiting, Chemotherapy-induced Nausea and Vomiting, Chemotherapy-induced Nausea and Vomiting, Chemotherapy-induced Nausea and Vomiting, Chemotherapy-induced Nausea and Vomiting
Treatment Olanzapine+NK-1 RA+5-HT3 RA, Dexamethasone+NK-1 RA+5-HT3 RA
Clinical Study IdentifierNCT04437017
SponsorFifth Affiliated Hospital, Sun Yat-Sen University
Last Modified on22 February 2021

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