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 (original) (raw)
Related papers
Double-Blind, Placebo-Controlled, Randomized Trial of Octreotide in Malignant Bowel Obstruction
Journal of Pain and Symptom Management, 2015
Context. Does octreotide reduce vomiting in cancer-associated bowel obstruction? Objectives. To evaluate the net effect of adding octreotide or placebo to standardized therapies on the number of days free of vomiting for populations presenting with vomiting and inoperable bowel obstruction secondary to cancer or its treatment. Methods. Twelve services enrolled people with advanced cancer presenting with vomiting secondary to bowel obstruction where surgery or anti-cancer therapies were not indicated immediately. In a double-blind study, participants were randomized to placebo or octreotide (600 mg/24 hours by infusion). Both arms received standardized supportive therapy (infusion of ranitidine [200 mg/24 hours], dexamethasone [8 mg/24 hours], and parenteral hydration [10e20 mL/kg/24 hours]). The primary outcome was patient-reported days free of vomiting at 72 hours. Results. In a study that recruited to the numbers identified in its power calculation, 87 participants provided data at 72 hours (45, octreotide arm). Seventeen people (octreotide) and 14 (placebo) were free of vomiting for 72 hours (P ¼ 0.67). Mean days free of vomiting were 1.87 (SD 1.10; octreotide) and 1.69 (SD 1.15; placebo; P ¼ 0.47). An adjusted multivariate regression of the incidence of vomiting over the study showed a reduced number of episodes of vomiting in the octreotide group (incidence rate ratio ¼ 0.40; 95% CI: 0.19e0.86; P ¼ 0.019); however, people in the octreotide arm were 2.02 times more likely to be administered hyoscine butylbromide (P ¼ 0.004), potentially reflecting increased colicky pain. Conclusion. Although there was no reduction in the number of days free of vomiting, the multivariate analysis suggests that further study of somatostatin analogues in this setting is warranted.
Medical Treatment for Inoperable Malignant Bowel Obstruction: A Qualitative Systematic Review
Journal of Pain and Symptom Management, 2007
The use of symptomatic agents has greatly improved the medical treatment of advanced cancer patients with inoperable bowel obstruction. A systematic review of studies of the most popular drugs used in the medical management of inoperable malignant bowel obstruction was performed to assess the effectiveness of these treatments and provide some lines of evidence. Randomized trials that involved patients with a clinical diagnosis of intestinal obstruction due to advanced cancer treated with these drugs were reviewed. Five reports fulfilled inclusion criteria. Three studies compared octreotide (OC) and hyoscine butylbromide (HB), and two studies compared corticosteroids (CSs) and placebo. Globally, 52 patients received OC, 51 patients received HB, 37 patients received CSs, 15 patients received placebo, and 37 patients received both placebo and CSs. On the basis of these few data, the superiority of OC over HB in relieving gastrointestinal symptoms was evidenced in a total of 103 patients. The latter studies had samples more defined in terms of stage and inoperability, and had a shorter survival in comparison with studies of CSs (less than 61 days, most of them less than 20 days). Data on CSs are less convincing, due to the methodological weakness of existing studies. This review confirms the difficulties in conducting randomized controlled trials in this population.
Palliative Medicine
Background: Malignant bowel obstruction, a complication of certain advanced cancers, causes severe symptoms which profoundly affect quality of life. Clinical management remains complex, and outcome assessment is inconsistent. Aim: To identify outcomes evaluating palliative treatment for inoperable malignant bowel obstruction, as part of a four-phase study developing a core outcome set. Design: The review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA); PROSPERO (ID: CRD42019150648). Eligible studies included at least one subgroup with obstruction below the ligament of Treitz undergoing palliative treatment for inoperable malignant bowel obstruction. Study quality was not assessed because the review does not evaluate efficacy. Data sources: Medline, Embase, the Cochrane Database, CINAHL, PSYCinfo Caresearch, Open Grey and BASE were searched for trials and observational studies in October 2021. Results: A total of 4769 stu...
Supportive Care in Cancer, 2000
In advanced cancer patients with inoperable bowel obstruction, the administration of antisecretive and antiemetic drugs has proved to be effective in controlling gastrointestinal symptoms caused by bowel obstruction. However, controlled studies concerning the most effective antisecretive drug are lacking. The aim of this randomized controlled study was to determine whether octreotide or hyoscine butylbromide was the more effective antisecretive drug for use in states of inoperable bowel obstruction. Eighteen patients with inoperable bowel obstruction randomly received octreotide 0.3 mg daily (n=9) or hyoscine butylbromide (HB) 60 mg daily (n=9) s.c. The following parameters were measured: episodes of vomiting, nausea, drowsiness, continuous and colicky pain, using a Likert scale corresponding to a numerical value: (none 0, slight 1, moderate 2, severe 3) recorded before starting the treatment (T0) and 24 h (T1), 48 h (T2) and 72 h after (T3), and the mean daily amounts of fluids administered i.v. or s.c. during the period of study. Three patients dropped out of the study because data were incomplete. Octreotide treatment induced a significantly rapid reduction in the number of daily episodes of vomiting and intensity of nausea compared with HB treatment at the different time intervals examined. No relevant changes were found in dry mouth, drowsiness and colicky pain. Lower levels of hydration were associated with nausea regardless of the treatment. At the doses used in this study, octreotide was more effective than HB in controlling gastrointestinal symptoms of bowel obstruction. Further studies are necessary to understand the role of hydration more clearly in such a clinical situation.
Supportive Care in Cancer, 2022
Purpose To provide evidence-based recommendations on the management of malignant bowel obstruction (MBO) for patients with advanced cancer. Methods The Multinational Association for Supportive Care in Cancer (MASCC) MBO study group conducted a systematic review of databases (inception to March 2021) to identify studies about patients with advanced cancer and MBO that reported on the following outcomes: symptom management, bowel obstruction resolution, prognosis, overall survival, and quality of life. The review was restricted to studies published in English, but no restrictions were placed on publication year, country, and study type. As per the MASCC Guidelines Policy, the findings were synthesized to determine the levels of evidence to support each MBO intervention and, ultimately, the graded recommendations and suggestions. Results The systematic review identified 17,656 published studies and 397 selected for the guidelines. The MASCC study group developed a total of 25 evidence-based suggestions and recommendations about the management of MBO-related nausea and vomiting, bowel movements, pain, inflammation, bowel decompression, and nutrition. Expert consensus-based guidance about advanced care planning and psychosocial support is also provided. Conclusion This MASCC Guideline provides comprehensive, evidence-based recommendations about MBO management for patients with advanced cancer.
Quality of life of patients with gastrointestinal cancers undergoing chemotherapy
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2018
Findings regarding changes in the quality of life (QOL) of patients with gastrointestinal cancers (GI) undergoing chemotherapy (CTX) are inconclusive. Purpose was to evaluate for changes in QOL scores of patients with GI cancers over two cycles of CTX. Patients (n = 397) completed disease-specific [i.e., Quality of Life-Scale-Patient Version (QOL-PV)] and generic [12-item Medical Outcomes Study Short Form Survey (SF-12)] measures of QOL a total of six times over two cycles of CTX. Changes in these QOL scores were evaluated using bootstrapped multilevel regression with full information maximum likelihood estimation. Treatment group (i.e., with or without targeted therapy), age, number of metastatic sites, time from cancer diagnosis, number of prior cancer treatments, GI cancer diagnosis (i.e., colon/rectum/anal vs. other), and CTX regimen were evaluated as covariates in the conditional models for each of the QOL scores. During the second cycle of CTX, QOL-PV scores decreased in the w...
Colorectal Disease, 2019
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Annals of Oncology, 2020
level will be evaluated. OM occurrence and severity will be assessed using a template developed by Primary Endpoint Solutions and OM scores will be centrally assigned to the WHO, NCI-CTC and RTOG scales. The primary efficacy endpoint will be based on observed severity and (WHO grades 3 or 4) duration of OM incidence vs historical controls. PD tracking will measure total ROS/RNS, GSH/GSSG, regulation in plasma and buccal epithelial cells. Results: 10 pts completed the 50 & 100mg/day with no safety issues. Dose 150 mg/ day is ongoing with 3 pts. No early dose limiting toxicity (DLT) or serious Adverse Event linked to ST-617 were observed. The 100 mg/day dose has been well tolerated with no grade 4 OM. No CRT dose interruptions or delays due to OM has been observed. Total ROS/RNS levels in plasma and buccal samples shows significant decrease with increased ST-617 dosing from 50 to 100 mg/day. Conclusions: ST-617 administration shows a very good safety profile. Favorable signs of efficacy in preventing the duration and severity of OM with a physiologically relevant mode of action response have been noted. A randomized, controlled, double blind trial is planned with the recommended dose. Clinical trial identification: ST617-101 trial is registered in South Africa. The SAHPRA number is 20180138 ST617-101 trial is registered in Europe EUDRACT number: 2020-000774-19.
Supportive Care in Cancer, 2001
The paper highlights a series of questions that doctors need to consider when faced with end-stage cancer patients with bowel obstruction: Is the patient fit for surgery? Is there a place for stenting? Is it necessary to use a venting nasogastric tube (NGT) in inoperable patients? What drugs are indicated for symptom control, what is the proper route for their administration and which can be administered in association? When should a venting gastrostomy be considered? What is the role of total parenteral nutrition (TPN) and parenteral hydration (PH)? A working group was established to review issues relating to bowel obstruction in end-stage cancer and to make recommendations for management. A steering group was established by the (multidisciplinary) Board of Directors of the European Association for Palliative Care (EAPC) to select members of the expert panel, who were required to have specific clinical and research interests relating to the topic and to have published significant papers on advanced cancer patients in the last 5 years, or to have particular clinical expertise that is recognised internationally. The final constitution of this group was approved by the Board of the EAPC. This Working Group was made up of English, French and Italian physicians involved in the field of palliative care for advanced and terminal cancer patients; and of English, American and Italian surgeons who also specialized in artificial nutrition (Dr. Bozzetti) and a professor of health economics. We applied a systematic review methodology that showed the relative lack of RCTs in this area and the importance of retrospective and clinical reports from different authors in different countries. The brief was to review published data but also to provide clinical opinion where data were lacking. The recommendations reflect specialist clinical practice in the countries represented. Each member of the group was allocated a specific question and briefed to review the literature and produce a position paper on the indications, advantages and disadvantages of each symptomatic treatment. The position papers were circulated and then debated at a meeting held in Athens and attended by all panel members.