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

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)

The range and suitability of outcome measures used in the assessment of palliative treatment for inoperable malignant bowel obstruction: A systematic review

“…Nine studies focused exclusively on patients with colorectal cancers [45,57,60,73,74,77,89,92,93] , nine studies focused on patients with gynaecological cancers [32,37,61,69,79,80,86,87,94] . [22,29] covering the same RCT; 2 Including Hardy et al, 1998 [24] (majority ovarian).…”

Inoperable malignant bowel obstruction: palliative interventions outcomes – mixed-methods systematic review

“…1 People with MBO describe distressing abdominal pain and distension, nausea and vomiting, inability to eat and drink with a consequential reduction in quality of life (QoL), nutritional and performance status. [2][3][4][5] Surgery provides the best option for longer-term survival. [6][7][8] However, surgery is often contraindicated due to ascites, peritoneal carcinomatosis, multiple sites of obstruction, and poor functional and nutritional status.…”

“…Malignant bowel obstruction (MBO) is a serious complication of cancer, affecting an estimated 3%–15% of patients with cancer globally,1 and most common with primary cancers of gynaecological and gastrointestinal origin (50% and 28%, respectively) 1. People with MBO describe distressing abdominal pain and distension, nausea and vomiting, inability to eat and drink with a consequential reduction in quality of life (QoL), nutritional and performance status 2–5…”

Opportunities to Improve Symptom Control with Somatostatin Congeners in GEP-NETs: A Review of Key Issues

“…49 However, placebo-controlled studies often find similar improvements in both frequency of symptoms and QoL outcomes between octreotide and placebo-controlled groups. 48,50 Despite these mixed results, some societal guidelines, like ESMO, recommend administering octreotide IR, either subcutaneously or via continuous-infusion, to treat refractory symptoms. 51…”

“…In initial small‐scale studies using a continuous infusion of 300 μg/day, vomiting was generally controlled rapidly, with 92.8% patients achieving at least a partial response and 71.4% able to resume oral food intake [ 49 ]. However, placebo‐controlled studies often find similar improvements in both frequency of symptoms and QoL outcomes between octreotide and placebo‐controlled groups [ 48 , 50 ]. Despite these mixed results, some societal guidelines, like ESMO, recommend administering octreotide IR, either subcutaneously or via continuous infusion, to treat refractory symptoms [ 51 ].…”