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

BMC Cancer

Caitlin Sheehan¹  Katherine Clark²  Simon Eckermann³  Nikki McCaffrey⁴  Belinda Fazekas⁵  Meera Agar⁶  David C. Currow⁷  Jessica Lee⁸  Rohit Joshi⁹  Tegan Asser^1,10  Wendy Muircroft^1,11  Peter Allcroft^1,11 

[1] Calvary Heath Care, Kogarah, New South Wales, Australia;Cancer & Palliative Care Network, Northern Sydney Local Health District, St Leonards, New South Wales, Australia;Northern Clinical School, The University of Sydney, St Leonards, New South Wales, Australia;Centre for Health Service Development, Australian Health Services Research Institute, University of Wollongong, Wollongong, New South Wales, Australia;Deakin Health Economics, Centre for Population Health Research, School of Health and Social Development, Deakin University, Geelong, Victoria, Australia;Palliative & Supportive Services, Flinders University, Bedford Park, South Australia, Australia;IMPACCT, Faculty of Health, University of Technology, Ultimo, New South Wales, Australia;Australian National Cancer Symptom Trials Group, University of Technology Sydney, 2007, Ultimo, New South Wales, Australia;IMPACCT, Faculty of Health, University of Technology, Ultimo, New South Wales, Australia;Australian National Cancer Symptom Trials Group, University of Technology Sydney, 2007, Ultimo, New South Wales, Australia;Liverpool Hospital, South West Sydney Local Health District, Liverpool, New South Wales, Australia;IMPACCT, Faculty of Health, University of Technology, Ultimo, New South Wales, Australia;Australian National Cancer Symptom Trials Group, University of Technology Sydney, 2007, Ultimo, New South Wales, Australia;Wolfson Palliative Care Research Centre, University of Hull, HU6 7RX, Hull, England;IMPACCT, Faculty of Health, University of Technology, Ultimo, New South Wales, Australia;Concord Centre for Palliative Care, Concord Repatriation General Hospital, Concord, New South Wales, Australia;Medical Oncology, Lyell McEwin Hospital, Adelaide, South Australia, Australia;School of Medicine, Flinders University, Bedford Park, South Australia, Australia;Southern Adelaide Palliative Services, Southern Adelaide Local Health Network, Bedford Park, South Australia, Australia;

关键词: Patient-reported outcome measures;    Neoplasms;    Intestinal obstruction;    Terminal care;    Palliative care;    Randomised controlled trials;   

DOI  :  10.1186/s12885-020-07549-y

来源: Springer

【 摘 要 】

BackgroundThis 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.MethodsAdults 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.ResultsOne 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.ConclusionThe 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 registrationAustralian New Zealand Clinical Trials Registry ACTRN12608000211369 (date registered 18/04/2008)

【 授权许可】

CC BY