Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent CINV
Recruiting
Fifth Affiliated Hospital, Sun Yat-Sen University
Phase 3
2020-02-03
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.
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