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

Phase 3

Completed

Conditions: Chemotherapy-induced Nausea and Vomiting

Interventions: Drug: Olanzapine
Drug: Aprepitant
Drug: Palonosetron
Drug: Dexamethasone

Registration Number: NCT02484911

Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olanzapine regimen	Olanzapine	Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
Olanzapine regimen	Aprepitant	Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
Olanzapine regimen	Palonosetron	Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
Olanzapine regimen	Dexamethasone	Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
Control regimen	Aprepitant	Aprepitant in combination with palonosetron and dexamethasone
Control regimen	Palonosetron	Aprepitant in combination with palonosetron and dexamethasone
Control regimen	Dexamethasone	Aprepitant in combination with palonosetron and dexamethasone

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Receiving HEC With Complete Response in Overall Phase	0 to 120 hours	Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Proportion of Participants Receiving MEC With Complete Response in Overall Phase	0 to 120 hours	Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase	0 to 120 hours	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).
Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase	0 to 24 hours	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 ）
Proportion of Participants Receiving HEC With Complete Response in the Acute Phase	0 to 24 hours	Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase	24 to 120 hours	Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase	24 to 120 hours	Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase	24 to 120 hours	Overall Phase was defined as 24 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).
Proportion of Participants Receiving MEC With Complete Response in the Acute Phase	0 to 24 hours	Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase	0-120 hours	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).
Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase	0 to 24 hours	Overall Phase was defined as 0 to 24 hours following initiation of chemotherapy. No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase	24 to 120 hours	Overall Phase was defined as 24 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).