Acute lymphoblastic leukemia MedDRA version: 20.0 Level: LLT Classification code 10024338 Term: Leukemia lymphoblastic acute System Organ Class: 100000004864
Conditions
Interventions
Product Name: Hydrocortisone
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
Princess Máxima Center of Pediatric Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? yes Number of subjects for this age range: 105 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 - Pre-existing mental retardation - Current oral hydrocortisone use - Risperidone use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To validate that addition of physiological doses of hydrocortisone to standard dexamethasone treatment reduces side effects in the acute lymphoblastic leukemia patients that suffer from clinically relevant dexamethasone-induced neurobehavioral problems. This randomized controlled trial closed on 5-8-2020, since the endpoint of 50 patients was reached. However, to be able to answer our secondary research questions, inclusion will continue till a total of 105 patients in our prospective Identification study is reached. These patients will not be treated with hydrocortisone in the study. ;Secondary Objective: Intervention part - CLOSED -To examine clinically relevant dexamethasone induced sleeping problems and validate that hydrocortisone reduces these problems -To evaluate whether hydrocortisone improves quality of life in patients with dexamethasone induced neurobehavioral problems -To determine the frequency of patients that may benefit from hydrocortisone for direct frailty occurrence Identification part - CONTINUING To study: - the role of genetic variation in the pathophysiology of dexamethasone-induced neurobehavioral problems - the influence of psychosocial and environmental factors on dexamethasone-induced neurobehavioral side effects - the role of dexamethasone kinetics in the pathophysiology of dexamethasone-induced neurobehavioral problems - the prevalence of frailty and to study the effect of dexamethasone on frailty -To study the prevalence of nutrient deficiencies, their association with frailty and the effect of dexamethasone on these deficiencies;Primary end point(s): The primary outcome parameter of the Intervention study (RCT) is - The occurrence of neurobehavioral problems after 5 days of dexamethasone treatment with or without hydrocortisone addition. These neurobehavioral problems will be measured with the parent-reported strength and difficulty questionnaire (SDQ). The amount of patients (n=50) to answer this primary outcome, | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcome parameters of the RCT - CLOSED - The occurrence of dexamethasone related sleeping difficulties after 5 days of dexamethasone treatment with or without hydrocortisone, measured by the Sleep Disturbance Scale for Children (SDSC) and actigraphy. - Quality of life after 5 days of dexamethasone treatment with or without hydrocortisone, measured with the Pediatric Quality of Life questionnaire (PedsQL). - Frailty with or without hydrocortisone addition, measured through bio-impedance, ultrasonography and upper leg circumference, activiy questionnaire, timed Up and Go test, fatigue (PedsQL), hand grip and musculus rectus femoris strength (dynamometer) and the 'Time to rise from floor' test. We will contin ue to include patients in our Identification study. In this cohort (105 patients) we study possible determinants of the inter-patient variability in developing dexamethasone induced neurobehavioral and sleeping problems. We study: - The influence of carrier status of single nucleotide polymorphisms (SNPs) on the development of dexamethasone induced clinically relevant neurobehavioral problems. - The effect of dexamethasone kinetics on the development of dexamethasone induced clinically relevant neurobehavioral problems - The impact of psychosocial and environmental factors on the development of dexamethasone induced clinically relevant neurobehavioral problems. - The prevalence of frailty and muscle wasting after 5 days of dexamethasone treatment. - The prevalence of vitamin D and B as well as other nutrient deficiencies, the effect of dexamethasone on these deficiencies and the association between nutrient deficiencies and frailty occurrence;Timepoint(s) of evaluation of this end point: Before and after 5 days of dexamethasone treatment | — |
Countries
Netherlands
Contacts
Public ContactM.M. van den Heuvel-Eibrink
Princess Máxima Center of Pediatric Oncology
Outcome results
None listed