Study protocol for a double-blind, comparative, randomised Japanese trial of triplet standard antiemetic therapies with or without 5 mg olanzapine to prevent chemotherapy-induced nausea and vomiting for patients with breast cancer treated with an anthracycline/cyclophosphamide regimen (JTOP-B).

Rie Ozeki Hirotoshi IiharaMototsugu ShimokawaHironobu HashimotoMasakazu AbeToru MukoharaHiroko BandoToshinobu HayashiHitoshi KawazoeMasayo KomodaTakako Yanai TakahashiMitsue Saito

Published in: BMJ open (2022)

Japan Registry of Clinical Trials (jRCT) jRCT1031200134; protocol date: 30 July 2020, version: 1.3, approval: 25 August 2020.

Keyphrases

chemotherapy induced
clinical trial
phase ii
phase iii
open label
study protocol
double blind
randomized controlled trial
high dose
low dose
psychometric properties
energy transfer
placebo controlled
drug administration
newly diagnosed