Rix 2005.
Methods | Study type: prospective multi‐centre study Setting: Department of Pediatrics, Aalborg University Hospital, and Department of Pediatrics, Aarhus University Hospital, Skejby, Denmark. This information was based on additional information provided by trial authors. | |
Participants | 24 children (median age at diagnosis 4.5 years (range 1.8 to 14.6 years); 17 boys and 7 girls) with newly diagnosed ALL. 12 had standard‐risk ALL according to Nordic risk criteria, 7 had intermediate‐risk ALL, and 5 had high‐risk ALL. | |
Interventions | According to NOPHO ALL‐92 protocol:
Type of glucocorticoid therapy: All children received prednisolone (60 mg/m2/d, in 3 daily doses) during first 5 weeks of induction therapy followed by 9 days of tapering. All children received 1‐week courses of prednisolone (60 mg/m2/d) without tapering; children with intermediate‐ and high‐risk criteria received an additional 3‐week course of dexamethasone (10 mg/m2/d) with tapering over a 9‐day period.
Cumulative dose of glucocorticoid therapy: All children received 2100 mg/m2 + 157.5 mg/m2 prednisolone. In addition, they received several courses (not defined) of 420 mg/m2/d prednisolone. Intermediate‐ and high‐risk patients received an additional 210 mg/m2 + 26.25 mg/m2 dexamethasone.
Duration of glucocorticoid therapy: induction therapy: 35 days of prednisolone + 9 days tapering doses. Additional 7‐day courses of prednisolone. Intermediate‐ and high‐risk patients: additional 21 days dexamethasone + 9 days tapering doses
Methods of cessation of glucocorticoid therapy: 50% every 3 days over 9 days in total No control intervention |
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Outcomes | Specific HPA axis function test: low‐dose ACTH stimulation test (1 µg tetracosactide (Synacthen, Novartis) between 8 and 10 a.m. (basal cortisol and after 30 minutes)) Moment of testing: for each child: before 5‐week course of prednisolone (weeks 1 to 5) and on days 1, 3, and 5 after tapering was completed. Before 1‐week course of prednisolone (weeks 14 (standard risk), 28 (high risk), and 37 (intermediate risk)) and on day 2 after cessation. Before 3‐week course of dexamethasone (weeks 25 to 27 (intermediate risk) or 36 to 38 (high risk)), before tapering, and on days 1, 3, and 7 after tapering was completed. Tests were performed during treatment for ALL. Cutoff limits defined by original studies: low‐dose ACTH test: normal response > 500 nmol/L |
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Notes | Based on additional information provided by trial authors, 5 children were lost to follow‐up. Length of follow‐up after glucocorticoid therapy: varied Funding source: research grants from the Danish Cancer Society Declaration of interest among primary researchers: not mentioned |