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Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV)

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Aprepitant+palonosetron+dexamethasone

palonosetron+dexamethasone

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Nausea and Vomiting

Eligibility Criteria

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

Inclusion Criteria:

18 years of age or older
Histologically or cytologically confirmed nasopharyngeal carcinoma
Accept chemotherapy for the first time
Patients who will receive chemotherapy (docetaxel 60 mg/m2 intravenously (IV), cisplatin 60 mg/m2 IV, and 5-FU (5-Fluorouracil) 600 mg/m2 IV)
Written informed consent

Exclusion Criteria:

regnant 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aprepitant arm

Control arm

Arm Description

Aprepitant+palonosetron+dexamethasone

palonosetron+dexamethasone

Outcomes

Primary Outcome Measures

Complete response

The primary endpoint is the rate of patients achieving a complete response(defined as no emetic episode and no use of rescue medication) during over all time (0 to 120 hours post chemotherapy)

Secondary Outcome Measures

Acute Phase Response

To determine the effect on complete response(defined as no emetic episode and no use of rescue medication) rates in the acute (0 to 24 hours) phase of CINV.

Delayed Phase Response

To determine the effect on complete response (defined as no emetic episode and no use of rescue medication)rates in the delayed (>24 to 120 hours post chemotherapy) phase of CINV.

Functional Living Index -Emesis (FLIE)

Safety and tolerability as measured by the incidence and severity of adverse

To evaluate the safety and tolerability by the incidence and severity of adverse events during the treatment (0 to 120 hours post chemotherapy)

Full Information

NCT ID

NCT02933099

First Posted

October 7, 2016

Last Updated

October 11, 2016

Sponsor

Wuhan Union Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT02933099

Brief Title

Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting

Acronym

CINV

Official Title

Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting Following High-dose Cisplatin in Nasopharyngeal Carcinoma Patients：a Randomized Phase 3 Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2016 (undefined)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wuhan Union Hospital, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (PDA) with antiemetic combination of palonosetron and dexamethasone (PD) in nasopharyngeal carcinoma patients receiving docetaxel, cisplatin, and 5-FU based chemotherapy.

Detailed Description

Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant, palonosetron and dexamethasone .In the other group,patients will accept the same dose of 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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aprepitant arm

Arm Type

Experimental

Arm Description

Aprepitant+palonosetron+dexamethasone

Arm Title

Control arm

Arm Type

Active Comparator

Arm Description

palonosetron+dexamethasone

Intervention Type

Drug

Intervention Name(s)

Aprepitant+palonosetron+dexamethasone

Other Intervention Name(s)

PDA

Intervention Description

Patients will receive the chemotherapy drugs as well as the following antiemetic drugs: aprepitant (125 mg orally on day 1 and 80 mg orally on days 2 and 3) plus palonosetron 0.25 mg IV and dexamethasone (20 mg orally on day 1 and 8 mg orally on days 2 and 3)

Intervention Type

Drug

Intervention Name(s)

palonosetron+dexamethasone

Other Intervention Name(s)

Intervention Description

Patients will receive the chemotherapy drugs as well as the following antiemetic drugs: palonosetron 0.25 mg IV and dexamethasone (12 mg orally on day 1 and 8 mg orally on days 2 and 3)

Primary Outcome Measure Information:

Title

Complete response

Description

The primary endpoint is the rate of patients achieving a complete response(defined as no emetic episode and no use of rescue medication) during over all time (0 to 120 hours post chemotherapy)

Time Frame

Up to 10 days

Secondary Outcome Measure Information:

Title

Acute Phase Response

Description

To determine the effect on complete response(defined as no emetic episode and no use of rescue medication) rates in the acute (0 to 24 hours) phase of CINV.

Time Frame

0 to 24 hours post chemotherapy

Title

Delayed Phase Response

Description

To determine the effect on complete response (defined as no emetic episode and no use of rescue medication)rates in the delayed (>24 to 120 hours post chemotherapy) phase of CINV.

Time Frame

>24 to 10 days post chemotherapy

Title

Functional Living Index -Emesis (FLIE)

Time Frame

Up to 10 days

Title

Safety and tolerability as measured by the incidence and severity of adverse

Description

To evaluate the safety and tolerability by the incidence and severity of adverse events during the treatment (0 to 120 hours post chemotherapy)

Time Frame

Up to 10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years of age or older Histologically or cytologically confirmed nasopharyngeal carcinoma Accept chemotherapy for the first time Patients who will receive chemotherapy (docetaxel 60 mg/m2 intravenously (IV), cisplatin 60 mg/m2 IV, and 5-FU (5-Fluorouracil) 600 mg/m2 IV) Written informed consent Exclusion Criteria: regnant 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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting

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