Safety and Efficacy of Aprepitant for CINV in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy
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|ClinicalTrials.gov Identifier: NCT02445872|
Recruitment Status : Unknown
Verified August 2015 by Qiong Zhao, Zhejiang University.
Recruitment status was: Not yet recruiting
First Posted : May 15, 2015
Last Update Posted : December 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-Induced Nausea and Vomiting Lung Cancer||Drug: Aprepitant Drug: Palonosetron Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Safety and Efficacy of Aprepitant for Chemotherapy-Induced Nausea and Vomiting in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||May 2016|
Experimental: Arm A
Aprepitant: 125mg PO on day1, 80mg PO on day2 and day3. Palonosetron (a 5-HT3 receptor antagonist): 0.25 mg IV push on day 1 only. Dexamethasone: 5mg IV push once daily from day 1 to day 3,and 3.75mg PO on days 4-5.
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
Other Name: Emend
Active Comparator: Arm B
Palonosetron: 0.25 mg IV push on day 1 only. Dexamethasone: 5mg IV push once daily from day 1 to day 3,and 7.5mg PO on days 4-5.
- Complete Response [ Time Frame: 5 days after the end of chemotherapy ]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
- Complete Control (No emetic episode, no need for rescue medication, with a maximum grade of mild nausea) [ Time Frame: 5 days after the end of chemotherapy ]No emetic episode, no need for rescue medication, with a maximum grade of mild nausea
- Emesis-free [ Time Frame: 5 days after the end of chemotherapy ]Percentage of patients without emetic episodes
- Presence of nausea [ Time Frame: 5 days after the end of chemotherapy ]Presence of nausea graded according to Likert scale (none, mild, moderate and severe)
- Safety and tolerability (adverse events related to study drug administration) [ Time Frame: 5 days after the end of chemotherapy ]Number of patients experienced at least one adverse events related to study drug administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445872
|Contact: Qiong Zhao, MDemail@example.com|
|The first affiliated hospital, Zhejiang University|
|Hangzhou, Zhejiang, China, 310003|
|Principal Investigator:||Qiong Zhao, MD||The First Affiliated Hospital, Zhejiang University|