head and neck cancer
Conditions
Interventions
Aprepitant 125 mg PO on day 1 Aprepitant 80 mg PO on days 2 to 5 Granisetron 3 mg IV on days 1 to 4 Dexamethasone 8 mg IV on days 1 to 4
Sponsors
Department of otolaryngology , Nagasaki University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient is scheduled to receive his/her first course of 5-FU/cisplatin chemotherapy for head and neck cancer 2) Patient has not received highly or moderately emetogenic chemotherapy 3) Performance Status : 0-2
Exclusion criteria
Exclusion criteria: 1) Patient has a serious hepatic insufficiency or renal failure 2) Patient has nausea or vomiting within 24 hours prior to chemotherapy 3) Patient has been treated with antiemetic agents within 48 hours prior to chemotherapy 4) Patient has any illness (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis) caused nausea or vomiting except for chemotherapy-induced nausea and vomiting 5) Patient is scheduled to receive radiation therapy to the abdomen 6) Patient is judged inappropriate by the investigator as subject for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with Complete Response (no vomiting and no use of rescue therapy) in overall phase (8 days after administration of cisplatin on day 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The proportion of patients with Complete Response in acute phase (days 1 to 4 after administration of cisplatin on day 1) and delayed phase (days 5 to 8 after administration of cisplatin on day 1) 2) The proportion of patients with no vomiting in overall, acute, and delayed phase 3) The frequency of nausea and vomiting 4) Food Intake | — |
Countries
Japan
Contacts
Public ContactKotaro Ishimaru
Nagasaki University Hospital Department of otolaryngology
Outcome results
None listed