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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
25
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.
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.
Alberta Children's Hospital
Calgary, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
McMaster University Hospital
Hamilton, Ontario, Canada
Children's Hospital of Western Ontario
London, Ontario, Canada
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).
Time frame: 24-48 hours after first dose of dexamethasone
Headaches
Parent/patients are asked to document the worst headache of the day prior to bedtime daily on a visual analogue scale using the 6-face "happy face" scale ranging from 0 (no headache) to 5 (extreme headache).
Time frame: 0-48 hours after first dose of dexamethasone
Adverse events and side effects
These will be described with numbers, type and frequencies for the duration of the subjects participation in the study.
Time frame: Duration of participation in study
Quality of life
Parent/patient will complete a quality of life assessment within 14 days prior to starting radiation (including first day of radiation) and within 14 days post completion of radiation (including last day of radiation).
Time frame: Baseline and at end of participation in study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Hospital for Sick Children
Toronto, Ontario, Canada