Health-related quality of life in patients with inoperable malignant bowel obstruction: secondary outcome from a double-blind, parallel, placebo-controlled randomised trial of octreotide.

McCaffrey, N; Asser, T; Fazekas, B; Muircroft, W; Agar, M; Clark, K; Eckermann, S; Lee, J; Joshi, R; Allcroft, P; Sheehan, C; Currow, DC

Health-related quality of life in patients with inoperable malignant bowel obstruction: secondary outcome from a double-blind, parallel, placebo-controlled randomised trial of octreotide.

McCaffrey, N Asser, T Fazekas, B Muircroft, W Agar, M

Clark, K Eckermann, S Lee, J Joshi, R Allcroft, P Sheehan, C Currow, DC

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Publisher:: Springer Science and Business Media LLC
Publication Type:: Journal Article
Citation:: BMC cancer, 2020, 20, (1)
Issue Date:: 2020-10-31

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Field	Value	Language
dc.contributor.author	McCaffrey, N
dc.contributor.author	Asser, T
dc.contributor.author	Fazekas, B
dc.contributor.author	Muircroft, W
dc.contributor.author	Agar, M https://orcid.org/0000-0002-6756-6119
dc.contributor.author	Clark, K
dc.contributor.author	Eckermann, S
dc.contributor.author	Lee, J
dc.contributor.author	Joshi, R
dc.contributor.author	Allcroft, P
dc.contributor.author	Sheehan, C
dc.contributor.author	Currow, DC
dc.date.accessioned	2020-11-24T02:21:27Z
dc.date.available	2020-10-21
dc.date.available	2020-11-24T02:21:27Z
dc.date.issued	2020-10-31
dc.identifier.citation	BMC cancer, 2020, 20, (1)
dc.identifier.issn	1471-2407
dc.identifier.issn	1471-2407
dc.identifier.uri	http://hdl.handle.net/10453/144287
dc.description.abstract	BACKGROUND:This analysis aims to evaluate health-related quality of life (HrQoL) (primary outcome for this analysis), nausea and vomiting, and pain in patients with inoperable malignant bowel obstruction (IMBO) due to cancer or its treatments randomised to standardised therapies plus octreotide or placebo over a maximum of 72 h in a double-blind clinical trial. METHODS:Adults with IMBO and vomiting recruited through 12 services spanning inpatient, consultative and community settings in Australia were randomised to subcutaneous octreotide infusion or saline. HrQoL was measured at baseline and treatment cessation (EORTC QLQ-C15-PAL). Mean within-group paired differences between baseline and post-treatment scores were analysed using Wilcoxon Signed Rank test and between group differences estimated using linear mixed models, adjusted for baseline score, sex, age, time, and study arm. RESULTS:One hundred six of the 112 randomised participants were included in the analysis (n = 52 octreotide, n = 54 placebo); 6 participants were excluded due to major protocol violations. Mean baseline HrQoL scores were low (octreotide 22.1, 95% CI 14.3, 29.9; placebo 31.5, 95% CI 22.3, 40.7). There was no statistically significant within-group improvement in the mean HrQoL scores in the octreotide (p = 0.21) or placebo groups (p = 0.78), although both groups reported reductions in mean nausea and vomiting (octreotide p < 0.01; placebo p = 0.02) and pain scores (octreotide p < 0.01; placebo p = 0.03). Although no statistically significant difference in changes in HrQoL scores between octreotide and placebo were seen, an adequately powered study is required to fully assess any differences in HrQoL scores. CONCLUSION:The HrQoL of patients with IMBO and vomiting is poor. Further research to formally evaluate the effects of standard therapies for IMBO is therefore warranted. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12608000211369 (date registered 18/04/2008).
dc.format	Electronic
dc.language	eng
dc.publisher	Springer Science and Business Media LLC
dc.relation.ispartof	BMC cancer
dc.relation.isbasedon	10.1186/s12885-020-07549-y
dc.rights	info:eu-repo/semantics/openAccess
dc.rights	This is a post-peer-review, pre-copyedit version of an article published in BMC cancer. The final authenticated version is available online at: https://dx.doi.org/10.1186/s12885-020-07549-y.	en_US
dc.subject	1112 Oncology and Carcinogenesis, 1117 Public Health and Health Services
dc.subject.classification	Oncology & Carcinogenesis
dc.title	Health-related quality of life in patients with inoperable malignant bowel obstruction: secondary outcome from a double-blind, parallel, placebo-controlled randomised trial of octreotide.
dc.type	Journal Article
utslib.citation.volume	20
utslib.location.activity	England
utslib.for	1112 Oncology and Carcinogenesis
utslib.for	1117 Public Health and Health Services
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
pubs.organisational-group	/University of Technology Sydney
utslib.copyright.status	open_access	*
pubs.consider-herdc	false
dc.date.updated	2020-11-24T02:21:18Z
pubs.issue	1
pubs.publication-status	Published
pubs.volume	20
utslib.citation.issue	1

Abstract:

BACKGROUND:This analysis aims to evaluate health-related quality of life (HrQoL) (primary outcome for this analysis), nausea and vomiting, and pain in patients with inoperable malignant bowel obstruction (IMBO) due to cancer or its treatments randomised to standardised therapies plus octreotide or placebo over a maximum of 72 h in a double-blind clinical trial. METHODS:Adults with IMBO and vomiting recruited through 12 services spanning inpatient, consultative and community settings in Australia were randomised to subcutaneous octreotide infusion or saline. HrQoL was measured at baseline and treatment cessation (EORTC QLQ-C15-PAL). Mean within-group paired differences between baseline and post-treatment scores were analysed using Wilcoxon Signed Rank test and between group differences estimated using linear mixed models, adjusted for baseline score, sex, age, time, and study arm. RESULTS:One hundred six of the 112 randomised participants were included in the analysis (n = 52 octreotide, n = 54 placebo); 6 participants were excluded due to major protocol violations. Mean baseline HrQoL scores were low (octreotide 22.1, 95% CI 14.3, 29.9; placebo 31.5, 95% CI 22.3, 40.7). There was no statistically significant within-group improvement in the mean HrQoL scores in the octreotide (p = 0.21) or placebo groups (p = 0.78), although both groups reported reductions in mean nausea and vomiting (octreotide p < 0.01; placebo p = 0.02) and pain scores (octreotide p < 0.01; placebo p = 0.03). Although no statistically significant difference in changes in HrQoL scores between octreotide and placebo were seen, an adequately powered study is required to fully assess any differences in HrQoL scores. CONCLUSION:The HrQoL of patients with IMBO and vomiting is poor. Further research to formally evaluate the effects of standard therapies for IMBO is therefore warranted. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12608000211369 (date registered 18/04/2008).

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