Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin
Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: metoclopramide (Drug); placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Mahidol University Official(s) and/or principal investigator(s): Suthinee Ithimakin, MD, Principal Investigator, Affiliation: Faculty of medicine Siriraj Hospital
Summary
The objective of this study is to assess the efficacy and tolerability of metoclopramide
added to standard antiemetic regimen for prophylaxis of cisplatin-induced emesis.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Number of Patients Who Had Complete Response
Secondary outcome: Toxicities and Severity of Nausea and Vomiting
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Division of medical oncology, department of medicine Siriraj Hospital, Bangkok 10700, Thailand
Additional Information
Starting date: April 2009
Last updated: November 4, 2010
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