Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting (AOPDPCINV)

Harbin Medical University

Status and phase: Completed; Phase 3

Conditions: Chemotherapy-induced Nausea and Vomiting

Treatments: Drug: Aprepitant; Drug: Dexamethasone; Drug: Olanzapine; Drug: Palonosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT02484911

GHYDZ-1225

Details and patient eligibility

About

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.

Full description

Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant,olanzapine ,palonosetron and dexamethasone .In the other group,patients will accept the same dose of aprepitant ,palonosetron and dexamethasone .During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV,nausea patients will be measured by a visual analogue scale (VAS) ,other adverse events should be recorded as well.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years of age or older
2. Histologically or cytologically confirmed malignant disease
3. Accept chemotherapy for the first time
4. 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)
5. Written informed consent

Exclusion criteria

1. Pregnant 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Olanzapine regimen

Experimental group

Description:

Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.

Treatment:

Drug: Aprepitant

Drug: Olanzapine

Drug: Palonosetron

Drug: Dexamethasone

Control regimen

Other group

Description:

Aprepitant in combination with palonosetron and dexamethasone

Treatment:

Drug: Aprepitant

Drug: Palonosetron

Drug: Dexamethasone