Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093690
• Other study ID #: Si094/2009
• Status: Completed
• Phase: N/A
• First received: March 24, 2010
• Last updated: November 4, 2010
• Start date: April 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• metoclopramide
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg oral four times a day on day 2-5
• placebo
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus placebo 20 mg oral four times a day on day 2-5

Locations

Country	Name	City	State
Thailand	Division of medical oncology, department of medicine Siriraj Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Who Had Complete Response	number of patients who experience no emesis and need no rescue treatment in 5-day period	5 days after receiving chemotherapy	No
Secondary	Toxicities and Severity of Nausea and Vomiting		5 days after receiving chemotherapy	Yes