Headache, Vomiting
Conditions
Keywords
Pediatrics, Vomiting, Headache, Radiation Therapy
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.
Interventions
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.
Sponsors
C17 Council
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
for Enrolment: * Children between 2-18 years of age. * Children who underwent resection of a brain tumour with ≤ 1.5 cm2 residual tumour after surgical resection. * Children regardless of extent of leptomeningeal or spinal metastasis (M1-3) are eligible. * Children who undergo focal or whole brain (± spinal) radiation as part of their brain tumour treatment. * Children treated at one of the 16 tertiary care centers in Canada (CPBTC). * Patients on any anticonvulsive treatment are eligible. * Patients on concomitant chemotherapy while undergoing radiation are eligible. * Patients must be ≥ 24 hours steroid-free prior to starting radiation. * Parents/legal guardians have to have signed and dated an informed consent to allow study enrolment of their child. (As per institutional guidelines, patients over a certain age may have signed their own informed consent form.) * Patients \> 8 years of age should assent to study participation. * Patients less than 10 years of age should have a Lansky Score of \>/= 50. * Patients 10 years of age or older should have a Karnofsky Score of \>/= 50. If ECOG performance scale is used, patient should have a score of 0, 1 or 2.
Exclusion criteria
for Enrolment: * Children with residual brain tumour lesion \> 1.5 cm2 after surgical resection. * Children on steroids (dexamethasone) that will not be stopped ≥ 24 hours prior to start of radiation therapy. Inclusion Criteria for Randomization to a Dexamethasone treatment group: * Patients must have been enrolled on the Dexamethasone study prior to the start of radiation therapy. * Children who develop either symptoms of vomiting (defined as either retching or vomiting ≥ once per day) or headache (≥ 2 points increase in severity of the most intense headache/day) while undergoing irradiation. * Patients who are currently undergoing focal or whole brain (± spinal) radiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Canada
Outcome results
None listed