Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients

Phase 2/3 Completed 30 enrolled University of Alabama at Birmingham Mayo Clinic · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the use of olanzapine for the treatment of cancer patients with chronic nausea and/or vomiting unrelated to chemotherapy or radiation in a randomized placebo-controlled pilot trial.

Timeline

Start: 2017-07-12
Primary completion: 2019-07-12
Completion: 2020-09-15

Outcome

Met primary endpoint

paper After 1 week of treatment, the reduction in nausea scores in the olanzapine arm was 8 points (95% CI, 7-8) higher than that of the placebo arm. PMID 32379269 ↗

paper The primary 2-sided end point P value was <.001. PMID 32379269 ↗

Publications

Navari RM, Pywell CM, Le-Rademacher JG, White P, Dodge AB, Albany C, Loprinzi CL. Olanzapine for the Treatment of Advanced Cancer-Related Chronic Nausea and/or Vomiting: A Randomized Pilot Trial. JAMA Oncol. 2020 Jun 1;6(6):895-899. doi: 10.1001/jamaoncol.2020.1052.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olanzapine	Small molecule	5 mg	Oral