Phase 3
N=120
Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting
Chemotherapy-induced Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT02484911 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Proportion of Participants Receiving HEC With Complete Response in Overall Phase — 20; 15 Participants — p=0.397
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Olanzapine (Drug); Aprepitant (Drug); Palonosetron (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- First Affiliated Hospital of Harbin Medical University
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Receiving HEC With Complete Response in Overall Phase |
20; 15 | 0.397 |
| PRIMARY Proportion of Participants Receiving MEC With Complete Response in Overall Phase |
36; 40 | 1.0 |
| SECONDARY Proportion of Participants Receiving HEC With Complete Response in the Acute Phase |
20; 17 | — |
| SECONDARY Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase |
20; 15 | 0.397 |
| SECONDARY Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase |
17; 6 | 0.02 sig |
| SECONDARY Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase |
18; 15 | 1.0 |
| SECONDARY Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase |
17; 7 | 0.005 sig |
| SECONDARY Proportion of Participants Receiving MEC With Complete Response in the Acute Phase |
36; 41 | — |
| SECONDARY Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase |
36; 40 | 1.0 |
| SECONDARY Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase |
30; 30 | 0.283 |
| SECONDARY Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase |
35; 40 | 1.0 |
| SECONDARY Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase |
30; 31 | 0.246 |
Summary
The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in combination with olanzapine ,palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Histologically or cytologically confirmed malignant disease
- Accept chemotherapy for the first time
- Patients who will receive high emetogenic cancer chemotherapy (HEC) (cisplatin>=70mg/m2,adriamycin in combination with cyclophosphamide ,cyclophosphamide>=1500mg/m2,adriamycin>60mg/m2,epirubicin>90mg/m2,dacarbazine，ifosfamide>=2g/m2) or moderate emetogenic chemotherapy cancer (carboplatin>=300mg/m2,cyclophosphamide>=600-1000mg/m2,adriamycin>50mg/m2)
- Written informed consent
Exclusion Criteria
- Pregnant or breast-feeding
- Uncontrolled psychosis history
- Inability or unwillingness to understand or cooperate with study procedures
- Central nervous system tumors primary or secondary
- Concurrent abdominal radiotherapy
- History of uncontrolled diabetes mellitus
- Patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma.
- Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month
- Pre-existing nausea or vomiting
- Inadequate hematological function and abnormal liver and renal function.
- History of sensitivity to olanzapine
- Concurrent application of quinolone antibiotic therapy
- Treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy.
- Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
- Concurrent application of systemic corticosteroids
- Active infection or gastrointestinal dysfunction
Data sourced from ClinicalTrials.gov (NCT02484911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.