Acute lymphoblastic leukemia MedDRA version: 17.1 Level: LLT Classification code 10001690 Term: ALL System Organ Class: 100000004864
Conditions
Interventions
Product Name: not applicable
Product Code: not applicable
Pharmaceutical Form: Oral solution
INN or Proposed INN: hydrocortisone
CAS Number: 50-23-7
Current Sponsor code: ATC H02AB09
Other descriptive
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - written informed consent - age 3-16 - histologically or cytologically confirmed acute lymphoblastic leukemia - inclusion in DCOG ALL10 or ALL11 protocol or ALL R3 protocol - able to comply with scheduled follow-up. Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 - preexisting mental retardation syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: I. To study if dexamethasone toxicity; e.g. side-effects like diabetes mellitus, insulin resistance, visceral fat gain, hypertension and hypercholesterolemia are less severe during intervention treatment compared to placebo. II. To study the positive predictive value of novel in vivo diagnostic tests (consisting of salivary very low dose dexamethasone suppression test), on dexamethasone side-effects ;Main Objective: To reduce dexamethasone induced cerebral side-effects on mood, behaviour, and cognition by intervention treatment with physiological doses of cortisol compared to placebo.;Primary end point(s): Primary outcome parameter is the parent-reported strength and difficulty questionnaire in Dutch (SDQ-Dut) ;Timepoint(s) of evaluation of this end point: after 5 days of dexamethasone treatment with or without cortisol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome parameters are mood and behaviour questionnaires and (neuro-)cognitive tests and metabolic parameters;Timepoint(s) of evaluation of this end point: after 5 days of dexamethasone treatment with or without cortisol | — |
Countries
Netherlands
Contacts
Public ContactELT van den Akker
Erasmus MC
Outcome results
None listed