Aprepitant for Chemotherapy Induced Nausea and Vomiting in Chinese Advanced Non-small Cell Lung Cancers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-01

Study Completion Date

2018-01-31

Brief Summary

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Aprepitant is an oral neurokinin-1(NK-1) antagonist which is widely used for the prevention of chemotherapy-induced nausea and vomiting(CINV), it is metabolized by CYP34A, however, up to now it was still unknown the CINV control rate of aprepitant in Chinese non-small cell lung cancer(NSCLC) patients, we hypothesis that CYP3A4 and NK-1 polymorphism would influence aprepitant plasma concentration, which may lead to the individual difference of CINV control rate.

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Detailed Description

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Patients pathologic diagnosed of advanced non-small cell lung cancer, according to NCCN non-small cell lung cancer guide line(2014 V2),the patient should receive standard platinum based chemotherapy, are randomized divided into two groups, aprepitant group and placebo group. In aprepitant group, patients would receive aprepitant 125 mg at day1, then 80 mg at day2 and day3. In placebo group, patients would receive placebo from day1 to day3. In both group, dexamethasone and 5-HT inhibitor palonosetron were give at the same dose. During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV, other side-effects should be recorded. In aprepitant group, plasma should be taken for the analyze of plasma concentration, gene polymorphism of CYP3A4 and NK-1 should be analyzed for all the patients who received aprepitant if possible.

Conditions

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Carcinoma, Non-small Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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aprepitant group

Patients assigned to aprepitant group should receive aprepitant for the control of CINV, aprepitant 125 mg for day1, 80mg for day2 and day3.

Group Type EXPERIMENTAL

Aprepitant

Intervention Type DRUG

aprepitant should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.

placebo

Patients assigned to placebo group should receive placebo for the control of CINV compared with aprepitant group.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.

Interventions

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Aprepitant

aprepitant should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.

Intervention Type DRUG

placebo

placebo should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.

Intervention Type DRUG

Other Intervention Names

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Emend

Eligibility Criteria

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Inclusion Criteria

* patients pathologic diagnosed of advanced non-small cell lung cancer
* according to NCCN non-small cell lung cancer guide line(2014 V2), patients are suitable for platinum based chemotherapy.

Exclusion Criteria

* patients could not receive platinum based chemotherapy judged by clinical doctors
* pregnancy or breast-feeding women
* any serious disease which could not be controled
* urine protein≥++, or 24h urine protein\>1g
* less than 18 years old or more than 75 years old

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No