NCT01135550

Low Dose Versus Usual Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation

A RANDOMIZED CONTROLLED MULTICENTER NON-INFERIORITY TRIAL OF TWICE DAILY LOW DOSE DEXAMETHASONE VERSUS USUAL DOSE DEXAMETHASONE FOR SYMPTOM CONTROL IN CHILDREN WITH A BRAIN TUMOUR UNDERGOING CRANIAL OR CRANIOSPINAL RADIATION

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness of low dose dexamethasone versus high dose dexamethasone in the treatment of radiation induced vomiting.

Detailed description

Dexamethasone is an effective medication to ameliorate radiation induced headache and vomiting. In our Toronto experience dexamethasone in low doses (1 mg/m2/day) is sufficient in treating these symptoms. However this experience is not shared from many neuro-oncology centers of excellence that more commonly use 5 mg/m2/day according to the results of the trans-Canadian survey. A prospective multicenter trial evaluating the effectiveness of dexamethasone in different dose regimens in symptomatic children while undergoing CNS radiation will elucidate the appropriate dose.

Conditions

• Vomiting
• Headache

Interventions

Type	Name	Description
DRUG	High dose dexamethasone	Subject will receive 5 mg/m2 po divided in two doses. Dexamethasone 4mg/mL solution will be compounded into a 1mg/mL dosage form. If symptoms are well controlled over 2 weeks time, tapering of dexamethasone can be considered. It will be at the treating physician's discretion to decide the start of the tapering of dexamethasone. The weaning schedule will be the same in both intervention arms: halving the dose once weekly (week 1, week 2) while continuing to give two doses/day, one half morning dose at week 3 and every second day at week 4.
DRUG	Low dose dexamethasone	Subject will receive 1 mg/m2 po divided in two doses. Dexamethasone 4mg/mL solution will be compounded into a 1mg/mL dosage form. If symptoms are well controlled over 2 weeks time, tapering of dexamethasone can be considered. It will be at the treating physician's discretion to decide the start of the tapering of dexamethasone. The weaning schedule will be the same in both intervention arms: halving the dose once weekly (week 1, week 2) while continuing to give two doses/day, one half morning dose at week 3 and every second day at week 4.

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-06-02
• Last updated: 2016-05-05

Locations

5 sites across 1 country: Canada