Low Dose Versus Usual Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation
- Conditions
- HeadacheVomiting
- Interventions
- Registration Number
- NCT01135550
- Lead Sponsor
- The Hospital for Sick Children
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm Low dose dexamethasone Subjects scheduled to undergo radiation therapy are enrolled before the therapy is started. Once radiation therapy begins they will complete a daily diary about any headaches or nausea/vomiting they experience. If they experience increased headache or vomiting they will be randomized to receive either a high or a low dose of dexamethasone, to control these symptoms. Standard Arm High dose dexamethasone Subjects scheduled to undergo radiation therapy are enrolled before the therapy is started. Once radiation therapy begins they will complete a daily diary about any headaches or nausea/vomiting they experience. If they experience increased headache or vomiting they will be randomized to receive either a high or a low dose of dexamethasone, to control these symptoms.
- Primary Outcome Measures
Name Time Method Effectiveness of dexamethasone on vomiting 24-48 hours after first dose of dexamethasone 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).
- Secondary Outcome Measures
Name Time Method Headaches 0-48 hours after first dose of dexamethasone 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).
Adverse events and side effects Duration of participation in study These will be described with numbers, type and frequencies for the duration of the subjects participation in the study.
Quality of life Baseline and at end of participation in study 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).
Trial Locations
- Locations (5)
McMaster University Hospital
🇨🇦Hamilton, Ontario, Canada
Children's Hospital of Western Ontario
🇨🇦London, Ontario, Canada
BC Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada