Clinical trial · Interventional
Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting
Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting Following High-dose Cisplatin in Nasopharyngeal Carcinoma Patients:a Randomized Phase 3 Trial
NCT02933099CI-TRIAL-00024279CINVunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (PDA) with antiemetic combination of palonosetron and dexamethasone (PD) in nasopharyngeal carcinoma patients receiving docetaxel, cisplatin, and 5-FU based chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aprepitant+palonosetron+dexamethasone | Drug | — | UNRESOLVED |
| palonosetron+dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aprepitant arm
- description
- Aprepitant+palonosetron+dexamethasone
- interventionNames
- Drug: Aprepitant+palonosetron+dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- palonosetron+dexamethasone
- interventionNames
- Drug: palonosetron+dexamethasone
Primary outcomes (1)
- measure
- Complete response
- timeFrame
- Up to 10 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years of age or older 2. Histologically or cytologically confirmed nasopharyngeal carcinoma 3. Accept chemotherapy for the first time 4. Patients who will receive chemotherapy (docetaxel 60 mg/m2 intravenously (IV), cisplatin 60 mg/m2 IV, and 5-FU (5-Fluorouracil) 600 mg/m2 IV) 5. Written informed consent Exclusion Criteria: 1. regnant or breast-feeding 2. Uncontrolled psychosis history 3. Inability or unwillingness to understand or cooperate with study procedures 4. Central nervous system tumors primary or secondary 5. Concurrent abdominal radiotherapy 6. History of uncontrolled diabetes mellitus 7. Patients of prostatic hyperplasia ,paralytic ileus,narrow feet glaucoma. 8. Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month 9. Pre-existing nausea or vomiting 10. Inadequate hematological function and abnormal liver and renal function. 11. History of sensitivity to olanzapine 12. Concurrent application of quinolone antibiotic therapy 13. Treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy. 14. Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide) 15. Concurrent application of systemic corticosteroids 16. Active infection or gastrointestinal dysfunction
References
Publications (0)
Data not yet available
No reference posted for this study.