Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV)
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|ClinicalTrials.gov Identifier: NCT02933099|
Recruitment Status : Unknown
Verified October 2016 by Ting Hu, Wuhan Union Hospital, China.
Recruitment status was: Not yet recruiting
First Posted : October 14, 2016
Last Update Posted : October 14, 2016
Wuhan Union Hospital, China
Information provided by (Responsible Party):
Ting Hu, Wuhan Union Hospital, China
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.
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-induced Nausea and Vomiting||Drug: Aprepitant+palonosetron+dexamethasone Drug: palonosetron+dexamethasone||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||October 2016|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||December 2018|
Resource links provided by the National Library of Medicine
Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate Palonosetron Aprepitant
Experimental: Aprepitant arm
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)
Other Name: PDA
Active Comparator: Control arm
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)
Other Name: PD
Primary Outcome Measures :
- Complete response [ Time Frame: Up to 10 days ]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 [ Time Frame: 0 to 24 hours post chemotherapy ]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 [ Time Frame: >24 to 10 days post chemotherapy ]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) [ Time Frame: Up to 10 days ]
- Safety and tolerability as measured by the incidence and severity of adverse [ Time Frame: Up to 10 days ]To evaluate the safety and tolerability by the incidence and severity of adverse events during the treatment (0 to 120 hours post chemotherapy)
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