Study protocol for J-SUPPORT 1604 (J-FORCE): a randomized, double blind, placebo-controlled Phase III study evaluating olanzapine (5 mg) plus standard triple antiemetic therapy for prevention of chemotherapy induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy

Jpn J Clin Oncol. 2018 Oct 1;48(10):950-952. doi: 10.1093/jjco/hyy114.

Abstract

The Guidelines of the Japan Society of Clinical Oncology recommend standard triple antiemetic therapy with aprepitant, a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone for patients receiving highly emetogenic chemotherapy. Recently, a Phase III study demonstrated the significance of adding of olanzapine (10 mg) to standard triple antiemetic therapy. Olanzapine is associated with somnolence, and we have previously conducted a randomized Phase II study to evaluate the efficacy and safety of 10 mg and 5 mg olanzapine. Lower dose of olanzapine reduced the incidence of somnolence. Therefore, we conducted a randomized, double blind, placebo-controlled, Phase III study to evaluate the efficacy of olanzapine (5 mg) combined with standard triple antiemetic therapy for cisplatin-based highly emetogenic chemotherapy. This study initiated in Feb 2017. A total of 690 patients are planned to be enrolled over a period of 2 years. This study has been registered at the UMIN Clinical Trials Registry as UMIN000024676.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antiemetics / administration & dosage
  • Antiemetics / pharmacology
  • Antiemetics / therapeutic use*
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / pharmacology
  • Benzodiazepines / pharmacology
  • Benzodiazepines / therapeutic use*
  • Cisplatin / administration & dosage
  • Cisplatin / pharmacology
  • Cisplatin / therapeutic use*
  • Double-Blind Method
  • Emetics / pharmacology
  • Emetics / therapeutic use*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Nausea / drug therapy*
  • Olanzapine
  • Vomiting / chemically induced
  • Vomiting / drug therapy*
  • Young Adult

Substances

  • Antiemetics
  • Antineoplastic Agents
  • Emetics
  • Benzodiazepines
  • Olanzapine
  • Cisplatin