Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly or moderately emetogenic chemotherapy: a randomized, double-blind, placebo-controlled study

J Pain Symptom Manage. 2014 Mar;47(3):542-50. doi: 10.1016/j.jpainsymman.2013.05.003. Epub 2013 Jul 12.

Abstract

Context: Chemotherapy-induced nausea and vomiting (CINV) can severely impair patients' quality of life (QOL). Psychotropics, especially olanzapine, have a strong antiemetic effect.

Objectives: To determine whether olanzapine could reduce the frequency of CINV and improve patients' QOL during chemotherapy.

Methods: This was a randomized, double-blind, placebo-controlled trial. Forty-four patients scheduled to receive highly or moderately emetogenic chemotherapy were enrolled. All patients received a 5-hydroxytryptamine3 receptor antagonist, steroid, and neurokinin-1 receptor antagonist. Patients were randomly assigned to take 5 mg/day of oral olanzapine (OL group, n = 22) or placebo (control group, n = 22) daily from the day before chemotherapy (Day 0) to Day 5. The primary endpoint was the rate of patients who achieved total control (no vomiting, no use of rescue medications, and maximum nausea of <5/100mm on a visual analogue scale). The secondary endpoint was Functional Living Index-Emesis questionnaire score on Days 0 and 6.

Results: The rate of patients achieving total control was significantly higher in the OL group (86% and 64% in acute and delayed phases, respectively) than in the control group (55% and 23%, P = 0.045, P = 0.014, respectively). Furthermore, the OL group experienced a better QOL than the control group, as reported on the Functional Living Index-Emesis questionnaire (P = 0.0004).

Conclusion: The addition of 5mg/day of oral olanzapine to standard therapy can reduce the frequency of CINV and improve QOL of patients receiving highly or moderately emetogenic chemotherapy.

Keywords: FLI-E; Olanzapine; appetite improvement; chemotherapy-induced nausea and vomiting; delayed emesis.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Antiemetics / administration & dosage*
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / therapeutic use
  • Benzodiazepines / administration & dosage*
  • Double-Blind Method
  • Eating / drug effects
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Nausea / drug therapy*
  • Neurokinin-1 Receptor Antagonists / adverse effects
  • Neurokinin-1 Receptor Antagonists / therapeutic use
  • Olanzapine
  • Psychotropic Drugs / administration & dosage
  • Quality of Life
  • Serotonin 5-HT3 Receptor Antagonists / adverse effects
  • Serotonin 5-HT3 Receptor Antagonists / therapeutic use
  • Steroids / adverse effects
  • Steroids / therapeutic use
  • Treatment Outcome
  • Vomiting / chemically induced
  • Vomiting / drug therapy*
  • Young Adult

Substances

  • Antiemetics
  • Antineoplastic Agents
  • Neurokinin-1 Receptor Antagonists
  • Psychotropic Drugs
  • Serotonin 5-HT3 Receptor Antagonists
  • Steroids
  • Benzodiazepines
  • Olanzapine