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. 2017 Nov 6;2017(11):CD008727. doi: 10.1002/14651858.CD008727.pub4

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
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
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