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

First Affiliated Hospital of Harbin Medical University120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Chemotherapy-induced Nausea and Vomiting

Interventions

OlanzapineDRUG

5mg,twice a day orally on day 1 to day 4

AprepitantDRUG

125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.

PalonosetronDRUG

0.25mg IV 30-60min before chemotherapy on day 1

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Outcomes

Primary Outcomes

Proportion of Participants Receiving HEC With Complete Response in Overall Phase

Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

Time frame: 0 to 120 hours

Proportion of Participants Receiving MEC With Complete Response in Overall Phase

Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

Time frame: 0 to 120 hours

Secondary Outcomes

Proportion of Participants Receiving HEC With Complete Response in the Acute Phase

Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

Time frame: 0 to 24 hours

Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase

Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

Time frame: 24 to 120 hours

Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase

Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

Time frame: 0 to 120 hours

Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase

Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy. No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue ）

Data from ClinicalTrials.gov

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