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

February 13, 2017 updated by: First Affiliated Hospital of Harbin Medical University

Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting---A Randomized Single Center Phase III Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • First Affiliated Hospital of Harbin Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Olanzapine regimen
Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
Drug: Olanzapine
5mg,twice a day orally on day 1 to day 4
Drug: Aprepitant
125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.
Drug: Palonosetron
0.25mg IV 30-60min before chemotherapy on day 1
Drug: Dexamethasone
6mg IV on day 1 ，3.75mg IV on day 2 to 4
OTHER: Control regimen
Aprepitant in combination with palonosetron and dexamethasone
Drug: Aprepitant
125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.
Drug: Palonosetron
0.25mg IV 30-60min before chemotherapy on day 1
Drug: Dexamethasone
6mg IV on day 1 ，3.75mg IV on day 2 to 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Receiving HEC With Complete Response in Overall Phase
Time Frame: 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.
0 to 120 hours
Proportion of Participants Receiving MEC With Complete Response in Overall Phase
Time Frame: 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.
0 to 120 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Receiving HEC With Complete Response in the Acute Phase
Time Frame: 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.
0 to 24 hours
Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase
Time Frame: 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.
24 to 120 hours
Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase
Time Frame: 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).
0 to 120 hours
Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase
Time Frame: 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 ）
0 to 24 hours
Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase
Time Frame: 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).
24 to 120 hours
Proportion of Participants Receiving MEC With Complete Response in the Acute Phase
Time Frame: 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.
0 to 24 hours
Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase
Time Frame: 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.
24 to 120 hours
Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase
Time Frame: 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).
0-120 hours
Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase
Time Frame: 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).
0 to 24 hours
Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase
Time Frame: 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).
24 to 120 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Harbin Medical University

Collaborators

Harbin Medical University

Investigators

  • Principal Investigator: Daxin Zhang, MD, First Affiliated Hospital of Harbin Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (ESTIMATE)

June 30, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHYDZ-1225

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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