Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis
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|ClinicalTrials.gov Identifier: NCT00869310|
Recruitment Status : Terminated (we terminated the study before enrolling 303/560 due to a slow accrual)
First Posted : March 25, 2009
Last Update Posted : January 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Emesis||Drug: aprepitant + dexamethasone Drug: metoclopramide + dexamethasone||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||303 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis: a Double-blind Randomized Trial|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Dexamethasone plus Aprepitant
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.
Active Comparator: 2
dexamethasone plus metoclopramide
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.
- Percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after cisplatin administration [ Time Frame: 6 days ]
- Evaluation of the impact on quality of life of the two antiemetic regimens [ Time Frame: 6 days ]
- Evaluation of the prognostic factors of delayed emesis in patients receiving a combination of aprepitant, palonosetron, dexamethasone for the prevention of acute emesis [ Time Frame: 6 days ]
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): NCT00869310
|Terni, Italy, 05100|
|Principal Investigator:||Fausto Roila, MD||Oncology Division, S. Maria Hospital, Terni, Italy|