NCT00869310

Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis

Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis: a Double-blind Randomized Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: S. Maria Hospital, Terni · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to compare efficacy and tolerability of aprepitant plus dexamethasone versus metoclopramide plus dexamethasone in the prevention of cisplatin-induced delayed emesis in patients that received aprepitant, palonosetron and dexamethasone before chemotherapy administration for the prevention of acute emesis.

Detailed description

This is a phase III, double-blind, randomized trial, to evaluated the efficacy and safety of aprepitant for the prevention of delayed emesis in patients submitted for the first time to chemotherapy with cisplatin. The study will be carried out during the first cycle of chemotherapy. For the prevention of acute emesis, all patients will receive, before chemotherapy: * dexamethasone 12 mg iv, in 15 minutes, 30 minutes before chemotherapy * palonosetron 0.25 mg iv bolus, 30 minutes before chemotherapy * aprepitant 125 mg orally, 60 minutes before chemotherapy After 24 hours from chemotherapy administration, patients will be randomized to receive one of the following antiemetic treatments: A) dexamethasone 8 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on days 3-4 plus Metoclopramide 20 mg orally 4 times a day: 24 hours after chemotherapy and then at 4 pm, 7 pm, 10 pm on day 2 then at 7 am, 12 am, 5 pm, 10 pm on days 3-4. B) Dexamethasone 8 mg orally: 24 hours after chemotherapy (day 2) and then at 8 am on days 3-4 plus Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3. The patients will receive prochlorperazine suppositories as rescue medication, for important nausea and vomiting (\> 2 episodes) during days 1-5 after chemotherapy. The patients will receive a diary, which includes a Visual Analogue Scale (VAS) for nausea and vomiting evaluation. All patients will fill out the diary, in which, for 6 consecutive days (days 1-6), patients will report for each day the number of vomiting episodes, the intensity and duration of nausea, any antiemetic rescue medication and any adverse event and its treatment. In addition, on day 1 before chemotherapy and then on day 6, patients have to fill out the FLIE (Functional Living Index-Emesis), a questionnaire concerning the impact of nausea and vomiting on their quality of life. Primary end-point is the percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after cisplatin administration

Conditions

• Emesis

Interventions

Type	Name	Description
DRUG	aprepitant + dexamethasone	Dexamethasone 8 mg orally: 24 hours after chemotherapy (day 2) and then at 8 am on days 3-4 plus Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3.
DRUG	metoclopramide + dexamethasone	dexamethasone 8 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on days 3-4 plus Metoclopramide 20 mg orally 4 times a day: 24 hours after chemotherapy and then at 4 pm, 7 pm, 10 pm on day 2 then at 7 am, 12 am, 5 pm, 10 pm on days 3-4.

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-03-25
• Last updated: 2014-01-06

Locations

1 site across 1 country: Italy