UMIN000019122.

Methods	Randomised, phase 2 study with 2 arms comparison of aprepitant + palonosetron + dexamethasone vs palonosetron + dexamethasone Recruitment period: November 2011 to n.r. target sample size: 76 Masking: open‐label Baseline patient characteristics: n.r.
Participants	Inclusion criteria 20 years of age with gynaecological cancer and scheduled to receive single‐day chemotherapy with carboplatin target area under the concentration curve of 5, and paclitaxel at 175 mg/m² ECOG performance status 0 to 2 adequate renal function, adequate hepatic function, adequate marrow function all patients provided written informed consent for participation in the study Exclusion criteria receipt of any agent that could affect study results (such as an antiemetic, steroid, or pimozide) before the start of chemotherapy symptomatic brain metastasis, gastrointestinal obstruction, or any other condition that could provoke nausea and vomiting known allergy or severe reaction to any of the study drugs Mean/median age, years: n.r. Gender: female Tumour/cancer type: gynaecological cancer Chemotherapy regimen: carboplatin (area under the concentration curve of 5) and paclitaxel at 175 mg/m² Country: Japan
Interventions	Experimental: arm A p.o. administration of 125 mg aprepitant 90 min before administration of chemotherapy drug on Day 1 and of 80 mg on Days 2 and 3, and 0.75 mg + palonosetron administered i.v. on Day 1 + 6 mg dexamethasone administered i.v. on Day 1 and 4 mg dexamethasone administered p.o. on Days 2 and 3 Experimental: arm B 0.75 mg palonosetron administered i.v. on Day 1 + 6 mg dexamethasone administered i.v. on Day 1 and 4 mg dexamethasone administered p.o. on Days 2 and 3
Outcomes	Primary outcome complete response (CR, defined as complete absence of emetic events) in the delayed phase
Notes	main ID: JPRN‐UMIN000019122 sponsor: Juntendo Nerima Hospital

5‐FU: 5‐fluorouracil.

5‐HT₃: serotonin (5‐hydroxytryptamine).

AC: doxorubicin, cyclophosphamide.

ALT: alanine aminotransferase.

AST: aspartate aminotransferase.

CNS: central nervous system.

Cr: creatinine.

CPT‐11: camptothecin‐11.

CTCAE: Common Terminology Criteria for Adverse Events.

d: day (e.g., d1, d3).              

EC: epirubicin.

ECG: electrocardiogram. 

ECOG: Eastern Cooperative Oncology Group.

ESMO: European Society for Medical Oncology.

FAC: 5‐fluorouracil (5FU) + AC.

FEC: fluorouracil, epirubicin, cyclophosphamide.

FLIE: Functional Living Index‐Emesis.

FOLFILI: folinic acid, fluorouracil, and irinotecan.

FOLFOX: folinic acid, fluorouracil, and oxaliplatin.

g/L: gram per litre.

g/m²: gram per square meter.  

h: hour.

Hb: haemoglobin.

HBV: hepatitis B virus.

HCV: hepatitis C virus.

HEC: highly emetogenic chemotherapy.

HIV: human immunodeficiency virus.

IU: international unit.

i.v.: intravenous.

L: litre.

MASCC: Annual Meeting on Supportive Cancer Care.

MEC: moderately emetogenic chemotherapy.

mg: milligram.

mL/min: millilitre per minute.

msec: millisecond.

NCI: National Cancer Institute.

NK₁: neurokinin‐1.

n.r.: not reported.

NSCLC: non‐small cell lung carcinoma.

PLT: platelets.

p.o.: oral.

QD: once a day.

QTc: QT interval corrected for heart rate.

SOX: S‐1 plus oxaliplatin.

TBIL: total bilirubin.

ULN: upper limit of normal.

VAS: visual analogue scale.

VP‐16: etoposide.

VM‐26: teniposide.

vs: versus.

WBC: white blood cell count.

XELOX: capecitabine, oxaliplatin.