germ cell tumors
Conditions
Interventions
palonosetron 0.75 mg, iv (Day 1) dexamethasone 9.9 mg, iv (Day 1) dexamethasone 6.6 mg, iv (Days 2-8) aprepitant 125 mg, oral (Day 1) aprepitant 80mg, oral (Days 2-5)
Sponsors
Graduate School of Medicine and Public Health, Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed as germ cell tumor histologically and/or serologically. (2) Patients scheduled to receive 5-day fractionated chemotherapy with cisplatin in hospitalization. (3) 20 years old or older at time of registration. (4) ECOG PS of patients is 0-2. (5) Patients can fill a questionnaire appropriately. (6) Patients will provide written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients have primary or secondary brain and/or intestinal cancer. (2) History of hypersensitivity to any drugs included in the protocol therapy. (3) Patients developing vomiting or retching within 24 hours prior to beginning chemotherapy. (4) Patients receiving antiemetic agents including benzodiazepines within 48 hours prior to beginning chemotherapy. (5) Patients during treatment with pimozide. (6) Patients receiving at least one drug in the following drugs : macrolide antibiotics, azole antifungal agents, barbiturates, warfarin, phenytoin, diltiazem, midazolam, tolbutamide, hormonal contraceptives, HIV protease inhibitors. (7) Patients considered to be ineligible for this study by physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with complete response (no vomiting and no rescue medication) during Days 1-9. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The proportion of patients with CR in acute phase (Days 1-5) or delayed phase (Days 6-9). (2) Incidence and severity of nausea in the overall period, acute phase or delayed phase. (3) The proportion of patients receiving rescue medication. (4) The proportion of patients developing adverse drug reactions. | — |
Countries
Japan
Outcome results
None listed