Clinical trial NCT01135550: Low Dose Versus Usual Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Vomiting
Headache
Keywords: Pediatrics
Vomiting
Headache
Radiation Therapy
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: C17 Council
First posted: 2010-06-02
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Exclusion Criteria for Randomization to a Dexamethasone treatment group:

* Patients who were not enrolled on Dexamethasone study prior to start of radiation therapy.

Primary outcomes:
measure: Effectiveness of dexamethasone on vomiting
timeFrame: 24-48 hours after first dose of dexamethasone
Secondary outcomes:
measure: Headaches
timeFrame: 0-48 hours after first dose of dexamethasone
measure: Adverse events and side effects
timeFrame: Duration of participation in study
measure: Quality of life
timeFrame: Baseline and at end of participation in study
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster University Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital of Western Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Ute Bartels, MD
role: PRINCIPAL_INVESTIGATOR
References: