Cunha 2004.
Methods | Study type: prospective multi‐centre study Setting: Brazil (University Hospital of Federal University of Minas Gerais, Santa Casa de Misericórdia, and Hospital Felício Rocho, Belo Horizonte). This information was based on additional information provided by trial authors. | |
Participants | 35 children (median age at diagnosis/first HPA axis function test 6.9 years (range 1.2 to 14.4 years); 17 boys and 18 girls) with ALL | |
Interventions | Treatment according to the Brazilian Group for Treatment of ALL, 1993 protocol (GBTLI‐93). Specific medication not defined
Type of glucocorticoid therapy: dexamethasone (6 mg/m2/d, twice daily) given for 28 days
Cumulative dexamethasone dose: 183.75 mg/m2
Duration of glucocorticoid therapy: 28 days + 9 days tapering doses (in total, 37 days)
Methods of cessation of glucocorticoid therapy: dose reduction over 10 days (50% each 3 days, with complete withdrawal on the 10th day) No control intervention |
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Outcomes | Specific HPA axis function test: ovine CRH stimulus test at 8 a.m. (after an overnight fasting period), including cortisol basal morning value Moment of testing: before introduction of dexamethasone, on 8th and 28th days of dexamethasone use, and 48 hours and 1 month after cessation of dexamethasone. Tests were performed during treatment for ALL. Cutoff limits defined by original studies: baseline cortisol: 5 to 25 µg/dL (138.9 to 694.4 nmol/L); stimulated cortisol levels were compared with levels before treatment. |
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Notes | 7 children were lost to follow‐up at testing on the 8th and 28th days of dexamethasone use, 1 more child at 48 hours after cessation of dexamethasone, and 7 more children at 1 month after cessation of dexamethasone. Length of follow‐up after glucocorticoid therapy: 1 month Funding source: Fundação de Amparo à Pesquisa do Estado de Minas Gerais (FAPEMIG) Declaration of interest among primary researchers: not mentioned |