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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
First Affiliated Hospital of Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting focused on measuring chemotherapy nausea vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
June 22, 2015
Last Updated
February 13, 2017
Sponsor
First Affiliated Hospital of Harbin Medical University
Collaborators
Harbin Medical University
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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

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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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