Double blind placebo controlled randomized intervention study to validate the beneficial effect of hydrocortisone on dexamethasone-induced neurobehavioral side effects in pediatric acute lymphoblastic leukemia
Completed
- Conditions
- Acute lymphoblastic leukemiablood cancer10024324
- Registration Number
- NL-OMON50327
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 106
Inclusion Criteria
- Written informed consent
- Age 3-18
- Histologically or cytologically confirmed acute lymphoblastic leukemia (ALL)
- Inclusion in DCOG ALL medium risk group protocol
- Able to comply with scheduled follow-up
Exclusion Criteria
- Patient or parent refusal
- Anticipated compliance problems
- Underlying conditions which affect the absorption of oral medication
- Pregnant or lactating patients
- Current uncontrolled infection or any other complication which may interfere
with
dexamethasone treatment
- Language barrier
- Pre-existing mental retardation
- Current oral hydrocortisone treatment
- Current risperidone treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome parameter of the intervention study (RCT - now closed):<br /><br>- The occurrence of neurobehavioral problems after 5 days of dexamethasone<br /><br>treatment with or without hydrocortisone addition. These neurobehavioral<br /><br>problems will be measured with the parent-reported strength and difficulty<br /><br>questionnaire (SDQ). </p><br>
- Secondary Outcome Measures
Name Time Method