cervical cancer
Conditions
Interventions
aprepitant
observation
Sponsors
Nara Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. patients with chemoradiotherapy containinig weekly cisplatin in FIGO stage IB2, II, III, IVA cervical cancer. 2. cisplatin: 40mg/m2/week. 3. Performance Status: 0-2 4. Adequate organ functions. 5. patients who can mention a diary. 6. patients who have signed to an approved informed consent.
Exclusion criteria
Exclusion criteria: 1. patients with received pimozide. 2. patients with history of chemotherapy with cisplatin. 3. patients with vomiting within 24 hours before first administrating of cisplatin. 4. patients who have had any other cancer. 5. patients who are pregnant or breast feeding. 6. patients with severe complications (heart disease, uncontrolled diabetes,bleeding tendency). 7. patients with active infection disease whom steroid is inappropriate for. 8. patients who have a history of hypersensitivity to drugs. 9. patients who were administered drugs in the following, 5-HT3 blocker, phenothiazine, butyrophenone, benzamide, dopamine receptor antagonist. 10. patients who are considered to be inappropriate for this study judged by the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of nausea, vomiting, fatigue and headache as graded by CTCAE v.4.0 with or without aprepitant. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. the evaluation of QOL using FLIE. 2. the proportion of patients who completed more than 5 courses. 3. comparison of 6B-OHF in urine. 4. adverse events. | — |
Countries
Japan
Contacts
Public ContactNaoto Furukawa
Nara Medical University Department of Obstetrics and Gynecology
Outcome results
None listed