Aprepitant is an oral neurokinin-1(NK-1) antagonist which is used for the prevention of chemotherapy-induced nausea and vomiting (CINV). This phase II clinical trial was designed to evaluate the efficacy of aprepitant in the prevention of CINV with lung cancer patients receiving 3-day cisplatin-based chemotherapy.
Patients pathologic diagnosed of advanced non-small cell lung cancer, according to NCCN non-small cell lung cancer guide line(2015 V1).The patient should receive a 3-day cisplatin-based chemotherapy, are randomized divided into two groups, aprepitant group and placebo group. In aprepitant group, patients would receive aprepitant(125 mg po at day1, 80 mg at day2-3) combination with palonosetron and dexamethasone(5mg iv at day1-3, 3.75mg po at day4-5). In placebo group patients would receive palonosetron and dexamethasone(5mg iv at day1-3, 7.5mg po at day4-5).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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
Aprepitant:The first day, one 125 mg capsule will be administered per oral, 1 hour before chemotherapy. Thereafter one 80 mg capsule will be repeated daily between 8 to 10 a.m. during days 2 to 3
The first affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China
Complete Response
The primary endpoint is the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase
Time frame: 5 days after the end of chemotherapy
Complete Control (No emetic episode, no need for rescue medication, with a maximum grade of mild nausea)
No emetic episode, no need for rescue medication, with a maximum grade of mild nausea
Time frame: 5 days after the end of chemotherapy
Emesis-free
Percentage of patients without emetic episodes
Time frame: 5 days after the end of chemotherapy
Presence of nausea
Presence of nausea graded according to Likert scale (none, mild, moderate and severe)
Time frame: 5 days after the end of chemotherapy
Safety and tolerability (adverse events related to study drug administration)
Number of patients experienced at least one adverse events related to study drug administration.
Time frame: 5 days after the end of chemotherapy
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