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A randomised, double blind, placebo-controlled trial of megestrol acetate or dexamethasone in treating symptomatic anorexia in people with advanced cancer

Currow, David C, Glare, Paul, Louw, Sandra, Martin, Peter, Clark, Katherine, Fazekas, Belinda and Agar, Meera R 2021, A randomised, double blind, placebo-controlled trial of megestrol acetate or dexamethasone in treating symptomatic anorexia in people with advanced cancer, Scientific reports, vol. 11, no. 1, pp. 1-10, doi: 10.1038/s41598-021-82120-8.

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Title A randomised, double blind, placebo-controlled trial of megestrol acetate or dexamethasone in treating symptomatic anorexia in people with advanced cancer
Author(s) Currow, David C
Glare, Paul
Louw, Sandra
Martin, PeterORCID iD for Martin, Peter orcid.org/0000-0002-1214-5149
Clark, Katherine
Fazekas, Belinda
Agar, Meera R
Journal name Scientific reports
Volume number 11
Issue number 1
Article ID 2421
Start page 1
End page 10
Total pages 10
Publisher Nature Publishing Group
Place of publication London, Eng.
Publication date 2021-01-28
ISSN 2045-2322
2045-2322
Keyword(s) Science & Technology
Multidisciplinary Sciences
cancer
drug delivery
Summary This multi-site, double blind, parallel arm, fixed dose, randomised placebo controlled phase III study compared megestrol acetate 480 mg/day with dexamethasone 4 mg/day for their net effects on appetite in people with cancer anorexia. Patients with advanced cancer and anorexia for ≥ 2 weeks with a score ≤ 4 (0–10 numeric rating scale (NRS) 0 = no appetite, 10 = best possible appetite) were recruited. Participants received megestrol 480 mg or dexamethasone 4 mg or placebo daily for up to 4 weeks. Primary outcomes were at day 7. Responders were defined as having a ≥ 25% improvement in NRS over baseline. There were 190 people randomised (megestrol acetate n = 61; dexamethasone n = 67, placebo n = 62). At week 1 (primary endpoint), 79·3% in the megestrol group, 65·5% in the dexamethasone group and 58·5% in the placebo group (p = 0.067) were responders. No differences in performance status or quality of life were reported. Treatment emergent adverse events were frequent (90·4% of participants), and included altered mood and insomnia. Hyperglycemia and deep vein thromboses were more frequent when on dexamethasone than the other two arms. There was no difference in groups between the three arms, with no benefit seen over placebo with anorexia improving in all arms. Trail registration: The trial was registered on 19/08/2008 with the Australian New Zealand Clinical Trials Registry (ACTRN12608000405314).
Language eng
DOI 10.1038/s41598-021-82120-8
Indigenous content off
HERDC Research category C1 Refereed article in a scholarly journal
Free to Read? Yes
Persistent URL http://hdl.handle.net/10536/DRO/DU:30147772

Document type: Journal Article
Collections: Faculty of Health
School of Medicine
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.