Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting (AOPDPCINV)
Primary Purpose
Chemotherapy-induced Nausea and Vomiting
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Olanzapine
Aprepitant
Palonosetron
Dexamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting focused on measuring chemotherapy nausea vomiting
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
Sites / Locations
- First Affiliated Hospital of Harbin Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Olanzapine regimen
Control regimen
Arm Description
Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
Aprepitant in combination with palonosetron and dexamethasone
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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).
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 )
Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase
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
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 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.
Proportion of Participants Receiving MEC 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).
Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase
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
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).
Full Information
NCT ID
NCT02484911
First Posted
June 22, 2015
Last Updated
February 13, 2017
Sponsor
First Affiliated Hospital of Harbin Medical University
Collaborators
Harbin Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02484911
Brief Title
Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting
Acronym
AOPDPCINV
Official Title
Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting---A Randomized Single Center Phase III Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Harbin Medical University
Collaborators
Harbin Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting
Keywords
chemotherapy nausea vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olanzapine regimen
Arm Type
Experimental
Arm Description
Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
Arm Title
Control regimen
Arm Type
Other
Arm Description
Aprepitant in combination with palonosetron and dexamethasone
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
5mg,twice a day orally on day 1 to day 4
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Intervention Description
125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.
Intervention Type
Drug
Intervention Name(s)
Palonosetron
Intervention Description
0.25mg IV 30-60min before chemotherapy on day 1
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
6mg IV on day 1 ,3.75mg IV on day 2 to 4
Primary Outcome Measure Information:
Title
Proportion of Participants Receiving HEC With Complete Response in Overall Phase
Description
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
Title
Proportion of Participants Receiving MEC With Complete Response in Overall Phase
Description
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 Outcome Measure Information:
Title
Proportion of Participants Receiving HEC With Complete Response in the Acute Phase
Description
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
Title
Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase
Description
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
Title
Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase
Description
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
Title
Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase
Description
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 )
Time Frame
0 to 24 hours
Title
Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase
Description
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).
Time Frame
24 to 120 hours
Title
Proportion of Participants Receiving MEC With Complete Response in the Acute Phase
Description
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
Title
Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase
Description
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
Title
Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase
Description
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
0-120 hours
Title
Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase
Description
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).
Time Frame
0 to 24 hours
Title
Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase
Description
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).
Time Frame
24 to 120 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daxin Zhang, MD
Organizational Affiliation
First Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
12. IPD Sharing Statement
Citations:
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9629870
Citation
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Citation
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Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=Differential+involvement+of+neurotransmitters+through+the+time+course+of+cisplatin-induced+emesis+as+revealed+by+therapy+with+specific+receptor+antagonists
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/8232489
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=Effects+of+iron+and+deferoxamine+on+cisplatin-induced+emesis%3A+further+evidence+for+the+role+of+free+radicals
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/23598819
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=Diemunsch+P%2C+Grelot+L.+et+al.+Potential+of+substance+P+antagonists+as+antiemetics
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=The+novel+NK1+receptor+antagonist+MK-0869+(L-754%2C030)+and+its+water+soluble+phosphoryl+prodrug%2C+L-758%2C298%2C+inhibit+acute+and+delayed+cisplatin-induced+emesis+in+ferrets.+Neuropharmacology.
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/22141732
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/19775450
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/22024310
Description
Related Info
Learn more about this trial
Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting
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