- Title
- A randomised, double blind, placebo-controlled trial of megestrol acetate or dexamethasone in treating symptomatic anorexia in people with advanced cancer
- Creator
- Currow, David C.; Glare, Paul; Louw, Sandra; Martin, Peter; Clark, Katherine; Fazekas, Belinda; Agar, Meera R.
- Relation
- Scientific Reports Vol. 11, Issue 1
- Publisher Link
- http://dx.doi.org/10.1038/s41598-021-82120-8
- Publisher
- Nature Publishing Group
- Resource Type
- journal article
- Date
- 2021
- Description
- 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.
- Subject
- double blind placebo-controlled trial; megestrol acetate; dexamethasone; treatment; anorexia; cancer; SDG 3; Sustainable Development Goals
- Identifier
- http://hdl.handle.net/1959.13/1458376
- Identifier
- uon:45413
- Identifier
- ISSN:2045-2322
- Rights
- Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons .org/licenses/by/4.0/. © The Author(s) 2021.
- Language
- eng
- Full Text
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