Randomized, Placebo-controlled Trial of Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis in Patients Receiving High Dose Cisplatin in Routine Medical Practice
18 Years
N/A
Both
Cancer
Trial Information
Randomized, Placebo-controlled Trial of Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis in Patients Receiving High Dose Cisplatin in Routine Medical Practice
Ondansetron plus dexamethasone are standard emetic prophylactic agents for highly emetogenic
chemotherapy. Metoclopramide is a dopamine antagonist, which may enhance efficacy of
ondansetron and dexamethasone.
Inclusion Criteria:
- schedule to receive first cycle of cisplatin > 50 mg/m^2
- pathologically or histologically confirmed solid cancer
- more than 18 years old
- creatinine clearance more than 50 ml/min
- aminotransferase less than 2 times of upper normal limit
Exclusion Criteria:
- pregnant woman
- patients with episode of vomiting within 24 hours prior to chemotherapy session
- gut obstruction
- brain metastasis
- abdominal or pelvic irradiation
- no history of allergy to study drugs
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Number of Patients Who Had Complete Response
Outcome Description:
number of patients who experience no emesis and need no rescue treatment in 5-day period
Outcome Time Frame:
5 days after receiving chemotherapy
Safety Issue:
No
Principal Investigator
Suthinee Ithimakin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Faculty of medicine Siriraj Hospital
Authority:
Thailand: Ethical Committee
Study ID:
Si094/2009
NCT ID:
NCT01093690
Start Date:
April 2009
Completion Date:
October 2010
Related Keywords:
- Cancer
- chemotherapy induced nausea and vomiting, metoclopramide
Name | Location |
|---|
