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Completed

NCT Number: NCT01093690

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

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.

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Key information

Conditions

Cancer Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of medical oncology, department of medicine Siriraj Hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metoclopramide

Drug

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

Other names: plasil

Placebo

Drug

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

Primary outcomes

  1. Number of Patients Who Had Complete Response

    Time frame: 5 days after receiving chemotherapy

    number of patients who experience no emesis and need no rescue treatment in 5-day period

Secondary outcomes

  1. Toxicities and Severity of Nausea and Vomiting

    Time frame: 5 days after receiving chemotherapy

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Siriraj Hospital

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 26, 2010
Registry last updated
Dec 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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