Study aiming at reducing drug related side effects in children with acute lymphoblastic leukemia (ALL).

Conditions: Acute lymphoblastic leukemia
MedDRA version: 17.1Level: LLTClassification code 10001690Term: ALLSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-003815-46-NL

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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<br>;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 Outcome Measures

Name	Time	Method
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