Randomized crossover trial of Granisetron/Dexamethasone/Aprepitant versus Palonosetron/Dexamethasone/Aprepitant for the prevention of nausea and vomiting in patients receiving receiving Cisplatin containing chemotherapy for head and neck cancer

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: Aprepitant is administered orally at 125 mg/body 1 hour or 1 hour and half before Cisplatin administration. On day 2 and 3, Aprepitant is administrated orally at 80 mg/body. Granisetron 40 ug/body and Dexamethasone 12.3 mg/body are administered intravenously 30 min before Cisplatin administration. On day 2 and 3, Granisetron 40 ug/body and Dexamethasone 6.6 mg/body are administrated. Aprepitant is administered orally at 125 mg/body 1 hour or 1 hour and half before Cisplatin administration. On day 2 and 3, Aprepitant is administrated orally at 80 mg/body. Palonosetron 0.75 mg/body and Dexamethasone 12.3 mg/body are administered intravenously 30 min before Cisplatin administration. On day 2 and 3, Dexamethasone 6.6 mg/body are administrated. CONDITION: head and neck cancer PRIMARY OUTCOME: the proportion of patients with a Complete Protection during the overall phase(0‐120 h postchemotherapy), the proportion of patients with a Complete Response during the overall phase SECONDARY OUTCOME: 1)the proportion of patients with a Complete Protection during; the acute phase (0‐24 h postchemotherapy) and the delayed; phase (24‐120 h postchemotherapy); 2)the proportion of patients with a Complete Response during the overall phase and the acute phase and the delayed phase; 3)the proportion of patients with a Complete Control during the overall phase and the acute phase and the delayed phase; 4)the proportion of patients without nausea; 5)the proportion of patients without emesis; 6)time to treatment failure; 7)safety INCLUSION CRITERIA: 1) histologically or cytologically confirmed head and neck cancer 2) stage III‐IV head and neck cancer 3) without prior treatment 4) age: >=20 and <75 5) patients who are scheduled to receive high emetogenic chemotherapy (Cisplatin >=60 mg/m2) 6) sufficient function of important organs a)WBC: >=3,000/mm3 b)AST: <100 IU/L c)ALT: <100 IU.L d)Ccr: >=60 ml/min/body 7) Performance Statues: 0‐1(ECOG) 8) written informed consent
Epistemonikos ID: bea0d58b14e126deebbeedd3aad2642fb4bae8ae
First added on: Aug 22, 2024