Temazepam or Melatonin Versus Placebo for the Treatment of Insomnia in Advanced Cancer: A Three-Arm, Double-Blind, Phase III, Multicenter, Randomized Clinical Trial.

Mendis, R; Wong, A; Frenkel, S; Southcott, AM; Selman, CJ; Martin, J; Grobler, A; Currow, D; Agar, M; Le, B; Philip, J

Temazepam or Melatonin Versus Placebo for the Treatment of Insomnia in Advanced Cancer: A Three-Arm, Double-Blind, Phase III, Multicenter, Randomized Clinical Trial.

Mendis, R Wong, A Frenkel, S Southcott, AM Selman, CJ Martin, J Grobler, A Currow, D

Agar, M

Le, B Philip, J

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Publisher:: MARY ANN LIEBERT, INC
Publication Type:: Journal Article
Citation:: J Palliat Med, 2024
Issue Date:: 2024-09-20

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Field	Value	Language
dc.contributor.author	Mendis, R
dc.contributor.author	Wong, A
dc.contributor.author	Frenkel, S
dc.contributor.author	Southcott, AM
dc.contributor.author	Selman, CJ
dc.contributor.author	Martin, J
dc.contributor.author	Grobler, A
dc.contributor.author	Currow, D https://orcid.org/0000-0003-1988-1250
dc.contributor.author	Agar, M https://orcid.org/0000-0002-6756-6119
dc.contributor.author	Le, B
dc.contributor.author	Philip, J
dc.date.accessioned	2024-10-14T21:48:05Z
dc.date.available	2024-10-14T21:48:05Z
dc.date.issued	2024-09-20
dc.identifier.citation	J Palliat Med, 2024
dc.identifier.issn	1096-6218
dc.identifier.issn	1557-7740
dc.identifier.uri	http://hdl.handle.net/10453/181406
dc.description.abstract	Background: Sleep disturbance has a prevalence of 30-78% in patients with advanced cancer. While pharmacotherapy is common, randomized controlled studies (RCTs) investigating available agents are limited. This study examines the efficacy and safety of temazepam or melatonin versus placebo for sleep in advanced cancer. Methods: This is a multicenter, randomized, double-blind, placebo-controlled study of temazepam, melatonin prolonged release (PR) or placebo for insomnia in patients with advanced cancer, and an insomnia severity index (ISI) score of >11. Results: Twenty-one participants were randomized: nine to temazepam, eight to melatonin, and four to placebo. Baseline characteristics between groups were similar. The adjusted mean difference in day 8 ISI score versus placebo was -9.1 (95% confidence interval [CI] -17.5, 0.7, p = 0.04) for temazepam and -9.6 (95% CI -18,-1.2, p = 0.03) for melatonin PR. There was no improvement in global quality of life. Both agents were well tolerated. Conclusion: Temazepam and melatonin PR were associated with a clinically significant improvement in patient-reported insomnia severity compared with placebo. Findings need confirmation with larger patient numbers.
dc.format	Print-Electronic
dc.language	eng
dc.publisher	MARY ANN LIEBERT, INC
dc.relation.ispartof	J Palliat Med
dc.relation.isbasedon	10.1089/jpm.2024.0151
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject	1103 Clinical Sciences, 1110 Nursing, 1117 Public Health and Health Services
dc.subject.classification	Gerontology
dc.subject.classification	4203 Health services and systems
dc.subject.classification	4205 Nursing
dc.title	Temazepam or Melatonin Versus Placebo for the Treatment of Insomnia in Advanced Cancer: A Three-Arm, Double-Blind, Phase III, Multicenter, Randomized Clinical Trial.
dc.type	Journal Article
utslib.location.activity	United States
utslib.for	1103 Clinical Sciences
utslib.for	1110 Nursing
utslib.for	1117 Public Health and Health Services
pubs.organisational-group	University of Technology Sydney
pubs.organisational-group	University of Technology Sydney/Faculty of Health
pubs.organisational-group	University of Technology Sydney/UTS Groups
pubs.organisational-group	University of Technology Sydney/UTS Groups/Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT)
pubs.organisational-group	University of Technology Sydney/UTS Groups/INSIGHT: Institute for Innovative Solutions for Well-being and Health
utslib.copyright.status	closed_access	*
dc.date.updated	2024-10-14T21:48:04Z
pubs.publication-status	Published online

Abstract:

Background: Sleep disturbance has a prevalence of 30-78% in patients with advanced cancer. While pharmacotherapy is common, randomized controlled studies (RCTs) investigating available agents are limited. This study examines the efficacy and safety of temazepam or melatonin versus placebo for sleep in advanced cancer. Methods: This is a multicenter, randomized, double-blind, placebo-controlled study of temazepam, melatonin prolonged release (PR) or placebo for insomnia in patients with advanced cancer, and an insomnia severity index (ISI) score of >11. Results: Twenty-one participants were randomized: nine to temazepam, eight to melatonin, and four to placebo. Baseline characteristics between groups were similar. The adjusted mean difference in day 8 ISI score versus placebo was -9.1 (95% confidence interval [CI] -17.5, 0.7, p = 0.04) for temazepam and -9.6 (95% CI -18,-1.2, p = 0.03) for melatonin PR. There was no improvement in global quality of life. Both agents were well tolerated. Conclusion: Temazepam and melatonin PR were associated with a clinically significant improvement in patient-reported insomnia severity compared with placebo. Findings need confirmation with larger patient numbers.

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http://hdl.handle.net/10453/181406