gynecologic cancer
Conditions
Interventions
aprepitant+granisetron+dexamethasone+olanzapine(5mg)
Sponsors
Gifu University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with gynecologic cancer who are scheduled to receive carboplatin(AUC>=4)-based chemotherapy 2. Patients aged >= 20 years old and <= 80 years old 3. Patients with an ECOG Performance Status of 0 - 2 4. Patients with no symptomatic brain metastasis and carcinomatosis 5. Patients with no history of administration of moderate to high emetogenic chemotherapy 6. Patients who do not take a medicine regularly, for example, 5HT3 receptor antagonists, NK1 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers, antihistamine drugs, benzodiazepine agents, etc. 7. Patients who meet the following standard values in general clinical tests: AST and ALT <=100U/L Total bilirubin <=2.0mg/dL 8. Written informed consent
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity or allergy for study drugs or similar compounds. 2. Patients who need antiemetics at the enrollment. 3. Patients who start taking opioids within 48 hours prior to enrollment. 4. Patient with unstable angina, ischemic heart disease, cerebral hemorrhage or apoplexy, active gastric or duodenal ulcer within 6 months prior to enrollment. 5. Patients who have convulsive disorders requiring anticonvulsants therapy 6. Patients with ascites effusion requiring paracentesis 7. Patients who have gastrointestinal obstruction 8.Pregnant, breastfeeding or expecting women or who do not wish to use contraception 9. Patients who have psychosis or psychiatric symptoms that interferes with daily life 10. Patient who received abdominal or pelvic irradiation within 6 days prior to enrollment 11. Patients who had diabetes mellitus 12. Habitual smoker at enrollment 13. Other patients who are judged to be inappropriate for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (no emesis, no rescue medication) rate within 120 hours from the start of CBDCA administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete response (no emesis, no rescue medication) rate within 168 hours from the start of CBDCA administration. 2. Complete response rate during the acute (0-24h) phase. 3. Complete response rate during the delayed (24-120h or 24-168h) phase. 4. Complete control (no emetic episodes, no rescue medication use, and no more than mild nausea) rate for the acute, delayed and overall phases. 5. Total control rate (no emetic episodes, no rescue medication use, and no nausea) rate for the acute, delayed and overall phases. 6. Severity of nausea. 7. Severity of anorexia. 8. Severity of sleepiness and the impact on life 9. Adverse event | — |
Countries
Japan
Contacts
Public ContactHirotoshi Iihara
Gifu University Hospital Department of Pharmacy
Outcome results
None listed