A Randomized Controlled Multicenter Non-Inferiority Trial of Twice Daily Low Dose Dexamethasone Versus High Dose Dexamethasone for Symptom Control in Children With a Brain Tumour Undergoing Cranial or Craniospinal Radiation
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Effectiveness of dexamethasone on vomiting
The primary outcome will be the evaluation of effectiveness of dexamethasone on vomiting after 24-48 hours (after 2-4 doses of treatment). Vomiting is defined as either retching or vomiting and will be counted in events. The frequency of emetic episodes/day will be documented in the daily diary. The effectiveness of dexamethasone will be counted in number of episodes and evaluated on day 2 (48 hours after first dose).
24-48 hours after first dose of dexamethasone
Ute Bartels, MD
The Hospital for Sick Children, Toronto Canada
Canada: Health Canada