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

Mahidol University

Status: Completed

Conditions: Cancer

Treatments: Drug: placebo; Drug: metoclopramide

Study type: Interventional

Funder types: Other

Identifiers

NCT01093690

Si094/2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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162 participants in 2 patient groups, including a placebo group

metoclopramide

Experimental group

Description:

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 orally four times a day on day 2-5

Treatment:

Drug: metoclopramide

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo