UMIN000012500.

Study name	Effect of aprepitant for nausea and vomiting during paclitaxel + carboplatin (TC) therapy
Methods	Randomised, cross‐over, interventional study with 2 arms comparison of aprepitant + 5‐HT₃ receptor antagonist + dexamethasone vs 5‐HT₃ receptor antagonist + dexamethasone Target sample size: 50 Masking: open‐label Baseline patient characteristics: not available
Participants	Inclusion criteria 20 years of age and older gynaecological malignancy for which TC is taken as first‐line chemotherapy ECOG performance status < 2 Exclusion criteria ECOG performance status ≥ 2 judged as inadequate for inclusion in the study Mean/median age, years: not available Gender: female Tumour/cancer type: gynaecological malignancy Chemotherapy regimen: paclitaxel + carboplatin (TC) regimen Country: Japan
Interventions	Cross‐over study Experimental: arm A first course 5‐HT₃ receptor antagonist + dexamethasone i.v. second course 5‐HT₃ receptor antagonist + dexamethasone i.v. + aprepitant p.o. Experimental: arm B first course 5‐HT₃ receptor antagonist + dexamethasone i.v. + aprepitant p.o. second course 5‐HT₃ receptor antagonist + dexamethasone i.v.
Outcomes	Objective to review utility of aprepitant for antinausea effect during paclitaxel + carboplatin (TC) therapy for the patient with gynaecological malignancy
Starting date	18 January 2011
Contact information	Research contact: Masahide Ohmichi; Department of Obstetrics and Gynecology; Osaka Medical College; 2‐7, Daigaku‐machi, Takatsuki, Osaka; email: m‐ohmichi@poh.osaka‐med.ac.jp Public contact: Masanori Kanemura; Department of Obstetrics and Gynecology; Osaka Medical College; 2‐7, Daigaku‐machi, Takatsuki, Osaka; email: gyn044@poh.osaka‐med.ac.jp
Notes	self‐funded by Department of Obstetrics and Gynecology, Osaka Medical College unique ID issued by UMIN: UMIN000012500