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

Phase 2

• Conditions: head and neck cancer

• Registration Number: JPRN-UMIN000004826
• Lead Sponsor: Yokohama City University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-06
• Study Completion: 2014-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1) with seizure disorder needing anticonvulsants unless clinically stable 2) with vomiting, retching, or grade 2 or higher nausea according to CTCAE 3) with QTc prolongation by electrocardiography (QTc: >470 msec) 4) with severe allergy to Palonosetron, Granisetron, Aprepitant and Dexamethasone 5) pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant 6) receiving an antiemetic drug 7) receiving pimozide (orap) 8) with history of mental disorder or treating it at the moment 9) doctor's decision not to be registered to this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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