Package Insert Research Articles

Evaluating the adverse drug reactions to clozapine in populations of children and adolescents: insights from VigiBase data.

Pharmacovigilance findings have marked clozapine use. Prescribers and package inserts worldwide focus on clozapine-induced neutropenia. The literature on clozapine adverse drug reactions (ADRs) for those under age 18 and their associated fatal outcomes is limited. Reports to the World Health Organization's global pharmacovigilance database (VigiBase) were analyzed among patients under 18 years of age extending from clozapine's introduction to June 1, 2022. There were 2825 reports of clozapine, including 42 fatal outcomes (relative lethality = 1.5% vs. 11.7% in all ages). After 280 cases were excluded (clozapine exposure during pregnancy, accidental exposure or unclear age), 2455 were included with ADRs during therapeutic use. Decreased white blood cell (WBC) count provided the most frequent aggregated ADR, accounting for 934 cases (37% of 2545), with only 1 fatal outcome (0.01%, 1/934). Suicide explained 7 of 27 (26%) non-duplicated fatal outcomes. Next in importance was clozapine-induced gastrointestinal hypomotility (CIGH) with 3 cases (11% of 27) and neuroleptic malignant syndrome with 2 cases (7% of 27). Agranulocytosis, aspiration, myocarditis, myocardiopathy and ventricular arrythmia led to single fatal cases. Based on these new findings and recent literature in all ages, to prevent fatal outcomes, child and adolescent psychiatrists need to shift their focus from severe neutropenia to other ADRs including pneumonia, respiratory aspiration and CIGH. In spite of its potential toxicity during overdoses, clozapine may have specific and strong anti-suicidal effects when compared with other antipsychotics. Child and adolescent psychiatrists need to take extreme precautions to avoid intentional overdoses when prescribing clozapine to patients with suicide risk.

Risk of artery dissection during systemic exposure to vascular endothelial growth factor pathway inhibitors.

Whether or not vascular endothelial growth factor pathway inhibitors (VPIs) increase the risk of artery dissection is still unknown. This study aimed to quantitatively evaluate the possibility of artery dissection as a class effect of VPIs using nationwide real-world data. This cohort study was conducted based on the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), which spans nearly the entire Japanese population of over 100 million individuals. We included the patients prescribed with 12 types of VPIs between 2012 and 2020. The incidence rate (IR) ratio of artery dissection for each VPI were estimated in comparison with bevacizumab, the only VPI in Japan with artery dissection listed in the package insert. Artery dissection as an outcome was targeted for acute artery dissection requiring hospitalization (including dissecting aneurysm). As a reference, a natural IR standardized by sex and age of bevacizumab-prescribed patients was also estimated using the direct method for the general population of NDB. Of 503,342 patients, the IR of artery dissection for bevacizumab was 44.4 (/100,000 person-years), and the adjusted IR ratios for each VPI compared with bevacizumab were consistently similar to or >1.0. The IRs for each VPI were also higher than the crude natural IR (1.66/100,000 person-years; 95% CI: 1.59-1.73) and the standardized natural IR (2.18/100,000 person-years; 95% CI: 1.86-2.50). Real-world evidence suggests the risk of artery dissection as a class effect of VPIs. More attention on this risk will be necessary when using VPIs in clinical practice.

Patient education tools for chronic pain medications: Artificial intelligence chatbot versus traditional patient information leaflets

Patient education tools for chronic pain medications: Artificial intelligence chatbot versus traditional patient information leaflets

Appropriate use of single-dose injectable aripiprazole lauroxil in the treatment of schizophrenia

Abstract Introduction: Single-dose injectable aripiprazole lauroxil (SDIAL) is used with long-acting injectable (LAI) aripiprazole lauroxil in the treatment of schizophrenia. SDIAL can be used to either initiate treatment or supplement during maintenance when follow-up doses are not given within labeling recommendations. The primary objective was to determine the usage and appropriateness of SDIAL between the initiation and the maintenance supplementation use in a Medicaid database. The secondary objective was to determine the overall associated costs with the potentially inappropriate use of LAI aripiprazole lauroxil. Methods: International Classification of Diseases, 10th edition codes were used to identify adult patients with schizophrenia and related disorders (18-64 years) who received SDIAL and/or LAI aripiprazole lauroxil between 2018 and 2020 using MarketScan Medicaid databases. The appropriateness of SDIAL was determined by package insert labeling timelines for treatment initiation and maintenance supplementation. Two authors independently reviewed each SDIAL claim for appropriateness. Descriptive statistics were used to analyze the data. Results: After excluding possible billing errors, a total of 582 claims were identified for SDIAL. Of these, 21% were potentially inappropriate, with a higher proportion occurring during the maintenance phase. Overall, potential inappropriate use resulted in costs over $307 000. Discussion: It appears that prescribers should be better educated on the appropriate use of SDIAL during maintenance supplementation.

Advances in Factors Affecting ALDH2 Activity and its Mechanisms.

Aldehyde dehydrogenase 2 (ALDH2) is a mitochondrial enzyme primarily involved in the detoxification of alcohol-derived aldehyde and endogenous toxic aldehydes. It exhibits widespread expression across various organs and exerts a broad and significant impact on diverse acute cardiovascular diseases, including acute coronary syndrome, acute aortic dissection, hypoxic pulmonary hypertension, and heart failure. The ALDH2 rs671 variant represents the most prevalent genetic variant in East Asian populations, with carriage rates ranging from 30 to 50% among the Chinese population. Given its widespread presence in the body, the wide range of diseases it affects, and its high rate of variation, it can serve as a crucial tool for the precise prevention and treatment of acute cardiovascular diseases, while offering individualized medication guidance. This review aims to provide a comprehensive overview of the latest advancements in factors affecting ALDH2 activity, encompassing post-transcriptional modifications, modulators of ALDH2, and relevant clinical drugs.

Critical analysis of Echinacea preparations marketed in Germany.

Colds are the most common cause of incapacity to work in 2023 and therefore have a significant impact on the German economy. Echinacea preparations are considered a non-specific immune stimulant that is used as a phytotherapeutic agent for the treatment and prevention of colds. In the 2021 ZEIT ranking of the best-selling pharmacy-only medicines in Germany, four Echinacea preparations were among the top ten, and they experienced a new hype during the SARS-CoV-2 pandemic. In this study, 22 Echinacea monopreparations, which are approved as herbal medicinal products, were analyzed based on their package inserts. The preparations used in clinical studies were compared with the preparations available on the market with regard to the criteria of plant species used, plant part used, preparation (extract or pressed juice), drug-extract ratio, single dose administered, standardization of the preparations, prior performance of an ingredient analysis, galenics, dosage, duration of administration, and daily dose administered. The analysis revealed that the preparations available on the market are very heterogeneous. The composition can vary considerably in terms of ingredients. For customers, these products appear homogeneous in terms of their presentation on the market. The legal framework conditions promote this situation. The clinical studies are also unable to adequately reflect the market situation. New studies based on market reality, with an analysis of ingredients in the preparations used, a standardized study design, and the inclusion of hematological and biochemical parameters in the evaluation should improve this situation. Days of incapacity for work as an outcome parameter could be well suited.

Breastfeeding and contrast agents-A critical review and presentation of new aspects.

There are discrepancies between guidelines of scientific societies and information of the package inserts of contrast media concerning breastfeeding following the application of a contrast agent to the mother. The contents of different review articles reflect the opinion of scientific societies. Consequently, in clinical routine settings it is difficult to find the optimal advice for a breastfeeding woman and her baby. Therefore, the paper carefully summarized important information dealing with the topic 'breastfeeding and contrast media' from the literature. Among other things, the paper focuses on topics that are not yet taken into account in other reviews (e.g. approval for breastfeeding women, contrast agents that have been analysed in human breast milk). In this way, the review shows new aspects. It has been revealed that data concerning the amount of contrast agents in human breast milk as well as contrast medium absorption by the infants' intestine are sparse. Instead of them, a lot of speculations and incorrect conclusions do exist in the literature. Because studies are rare or missing, contrast media are not approved for breastfeeding women (off-label-use). Although breastfeeding women 100% prefers a break from breastfeeding, in current decision-making processes, their preference plays a minor role. However, this should change in the future. In addition, it would be very important to inform breastfeeding women in the future about the missing data concerning 'breastfeeding and contrast media'.

Optimizing Mechanical Properties of Recycled 3D-Printed PLA Parts for Sustainable Packaging Solutions Using Experimental Analysis and Machine Learning

Abstract: Increasing environmental concerns and the need for sustainable materials have driven a focus towards the utilization of recycled polylactic acid (PLA) in additive manufacturing as PLA offers advantages over other thermoplastics, including biodegradability, ease of processing, and a lower environmental impact during production. This study explores the optimization of the mechanical properties of recycled PLA parts through a combination of experimental and machine learning approaches. A series of experiments were conducted to investigate the impact of various processing parameters, such as layer thickness and infill density, as well as annealing conditions, on the mechanical properties of recycled PLA parts. Machine learning algorithms have proven the possibility to predict tensile behavior with an average error of 6.059%. The results demonstrate that specific combinations of processing parameters and post-treatment annealing differently improve the mechanical properties (with 7.31% in ultimate tensile strength (UTS), 0.28% in Young’s modulus, and 3.68% in elongation) and crystallinity (with 22.33%) of recycled PLA according to XRD analysis, making it a viable alternative to virgin PLA in various applications such as sustainable packaging solutions, including biodegradable containers, clamshell packaging, and protective inserts. The optimized recycled PLA parts exhibited mechanical properties and crystallinity levels comparable to those of their virgin counterparts, highlighting their potential for reducing environmental impact and saving costs. For both as-built and annealed samples, the optimal settings for achieving high composite desirability involved a 0.2 mm layer thickness, with 75% infill for the as-built samples and 100% infill for the annealed samples. This study provides a comprehensive framework for optimizing recycled PLA in additive manufacturing, contributing to the advancement of sustainable material engineering and the circular economy.

Evaluation of the Impact of Monitoring for Tumor Lysis During Venetoclax Ramp-Up in Chronic Lymphocytic Leukemia in Routine Clinical Practice.

Venetoclax has made a significant impact in the treatment of chronic lymphocytic leukemia (CLL) due to its ability to induce deep and durable remissions with a finite duration of oral therapy. However, it can lead to tumor lysis syndrome (TLS) which is mitigated with dose escalation strategies. Patients who initiate venetoclax need to follow rigorous, and potentially burdensome, TLS monitoring during dose ramp-up. The frequency with which this rigorous monitoring leads to therapeutic interventions in clinical practice has not been well described. We conducted a study to assess the incidence of TLS and interventions needed after initiation of venetoclax in patients with CLL. Adult patients with CLL who started treatment with venetoclax between July 2017 and March 2021 at Levine Cancer Institute were included in this study. Adherence to the venetoclax package insert (PI) for tumor lysis monitoring, incidence of laboratory as well as clinical TLS, and interventions resulting from the monitoring of TLS were collected. We report outcomes on 73 consecutive patients with CLL who initiated venetoclax. The majority of patients had low (49%) or medium (44%) tumor burden. During venetoclax ramp-up, 66% of patients adhered strictly to TLS monitoring as per the venetoclax PI. One patient developed laboratory TLS, and no patients developed clinical TLS. Six patients received unplanned interventions to treat TLS; all had medium or high tumor burden. There were no unplanned interventions in patients with low tumor burden. In patients with low and medium tumor burden CLL who start venetoclax, the incidence of TLS is very low, and interventions are uncommonly needed.

Towards streamlined product information: reporting of transporter-mediated drug interactions.

The purpose of this study is to investigate the reporting of risks associated with transporter-mediated drug-drug interactions (DDIs) in medicinal product information and to identify suitable wording for future standardisation of summaries of product characteristics (SmPCs). The SmPCs of medicinal products approved in the European Union from 2012 to 2023 were screened for warnings on Organic Anion Transporting Polypeptide 1B1 and 1B3 (OATP1B1 and OATP1B3), and Breast Cancer Resistance Protein (BCRP). An in-house search engine for product information was used. Warnings were categorised into different DDI scenarios based on the SmPC texts. A total of 192 out of 859 approved medicinal products had SmPC text pertaining to OATP1B1, 1B3 and/or BCRP. The majority of products had text for all three transporters Most texts were located in SmPC Sect.5.2, followed bySect. 4.5. Numerous interaction-texts either concluded that the interaction lacked clinical relevance or lacked information on the clinical relevance of the finding. The highest number of SmPC texts indicating a clinically relevant interaction with outlined clinical consequences was found for BCRP. The article also presents SmPC texts for each DDI scenario, which the authors consider as examples of explicitwordings with actionable recommendations. A potential for improvement of SmPC text for transporter-mediated DDI was identified: Warnings without clinical relevance could be omitted, and some warnings with clinical relevance could be updated to provide actionable recommendations to the prescribers. A selection of unambiguous texts was identified as starting point to generate standard texts.

Legal and scientific deficiencies of drug advertisements on German television.

Drug advertising primarily serves to publicize the product and increase sales. The legal requirements in the Therapeutic Products Advertising Act (Heilmittelwerbegesetz, HWG) in Germanyare intended to protect consumers. However, a lack of information about the potentialnegative aspects of drugs represents a risk for viewers. In this study, we analyzed a total of 52 advertising clips for drugs, food supplements, and medical products on public and private German television. These short films in the commercial breaks between the TV programs serve to publicize and advertise products. Furthermore, the corresponding package inserts for the drugs and the content and structure of the advertising clips were analyzed. The clips were compared with each other as well as about the mandatory information according to §4 of the HWG and §11 of the Medicinal Products Act (Arzneimittelgesetz, AMG). The study revealed that a large proportion of the mandatory information was not included in the advertising clips analyzed. Not all legal requirements were met in the package inserts either. Alarmingly, the advertising clips consistently contained only one of the mandatory information pieces, namely, the name of the product. Adverse effects were not mentioned in any advertising clip, and the effects of drugs were only poorly explained, if at all. Overall, scientific content of the advertisements was minimal if at all present. Instead, the airtime was dominated by emotional and attention-grabbing content in the form of a frame story, whereas the potential to educate people about medicines and raise public awareness remains mostly unused. Thus, drug advertisements on German television exhibit substantial scientific and legal deficiencies. In addition, we noted several legal gray zones in advertisements. The deficiencies in drug advertisement quality on television are, unfortunately, in line with quality deficiencies on drug advertisements in various other platforms (see., e.g., https://pubmed.ncbi.nlm.nih.gov/37792047/ ; https://pubmed.ncbi.nlm.nih.gov/38430230/ ). Thus, the lack of rigorous implementation of the HWG is a general problem in Germany. We make specific suggestions on what actions should be taken to improve the implementation of the HWG in television advertisements to improve drug safety and consumer safety.

Strategies to Improved Breast Cancer Treatment Associated With Cardiotoxicity

Abstract. In recent years, breast cancer has developed rapidly. Many women suffer from breast cancer, making the study of its treatment extremely important. The drugs used in breast cancer therapy have shown beneficial effects, but some cause cardiotoxic side effects wich deserve close attention. Cardiotoxicity includes a range of effects, such as arrythmia, cardiac dyfunction and even heart failure, which could be a threaten to life health. Therefore, it is crucial and necessary to deal with the cardiotixicity side effect during breast cancer therapy. Doing so will provide patients better options for their treatment. Three drugs have been proven to have cardiotoxic effects, including anthracyclines(eg:Doxorubicin), HER-2-targeting drug(Tratzutmab), and Cyclophosphamide. Although numerous studies have extensively researched how to mitigate the cardiotoxic effects of anti-breast cancer drugs, few articles have summarized and discussed these findings. This current situation results in a lack of comprehensive treatment plans in clinical practice. Therefore, this paper aims to review these studies and discuss the main drugs used to reduce the toxicity of three commonly used antineoplastic agents, in the hope of providing more comprehensive guidance for clinical medication.

Trends in complexity of single-agent and combination therapies for solid tumor cancers approved by the US Food and Drug Administration.

Many FDA-approved cancer therapies, whether as a multiagent combination or as a single agent, have demonstrated only modest clinical benefit. To investigate the drug development landscape, this analysis focuses on whether newly approved drugs are added to existing standards as combination therapy or replace a former drug as monotherapy. A retrospective analysis of package inserts and corresponding trials for the treatment of nonhematology solid tumor malignancies from January 2011 to December 2023 was conducted to categorize an approval as monotherapy or combination therapy. Drug characteristics, treatment indications, study design, approval history, and efficacy results were compared between the 2 cohorts. Among the 292 approval entries and 110 drugs, 193 (66.1%) were monotherapies and 99 (33.9%) were combinations. Combinations, when compared with monotherapies, were more frequently approved as regular than accelerated approval (85 [85.9%] vs 132 [68.4%], P <.01), in the first-line setting (66 [66.7%] vs 69 [35.8%], P <.01), and with overall survival as the criteria (49 [49.5%] vs 40 [20.7%], P <.01). Monotherapies were more likely to be novel drugs compared with combinations (80 [41.5%] vs 14 [14.1%] P <.01). Monotherapies were more likely to be small molecule targeted agents, while combinations were more likely to be immunotherapies (P <.02). There was no difference comparing the time-to-event endpoints and validated clinical benefit scale, but the median response rate of combinations (46%) was higher than monotherapies (34%, P <.01). Given that clinical benefit appears limited in combination therapy compared with monotherapy, drug development could focus on simplifying cancer therapies toward patient-centered paradigms.

Knowledge, attitudes and practices regarding medication splitting and crushing among the general public in Jordan: a cross-sectional study

BackgroundSplitting or crushing medications are used for dosage administration when a certain dose is not easily accessible. Understanding the splitting or crushing of medications is essential to guarantee safe medication...

European Pharmaceutical Industry Medical Information: A Role to Play in the Provision of Medicine-Related Information to Patients.

European pharmaceutical companies have a professional and legal obligation to provide objective, factual and non-promotional medicine-related information to both healthcare professionals (HCPs) and patients on request and have establishedMedical Information services to fulfil this need. Also, medicines are supplied with a package leaflet for patients and/or users-this usually includes the contact details for the company's Medical Information service. There is a large scale of patient enquiry interactions across the European region. A survey conducted in 2021 by the Medical Information Leaders in Europe (MILE) association revealed that 21% of all enquiries managed by Medical Information services in 2020 were from non-HCPs. Eighteen companies collectively managed over 140,000 non-HCP enquiries-while supporting so many patients, this is also a potentially rich source of insights to real-life patient experiences. When interacting with patients, companies are cautious not to interfere with the relationship between the patient and their HCP. This can limit the information provided, with many being referred to their busy treating physicians. Unfortunately, this approach can fall short of patients' expectations or needs. MILE recognises the potential to be more helpful and companies are keen to evolve to deliver more patient-centric support. MILE member companies have collaborated in the collation and publication of best-practice principles for handling unsolicited requests for medicine-related information from patients, caregivers and members of the general public (MOPs). This will help improve accessibility to quality information support, harmonise the patients' experience and build confidence in the pharmaceutical industry services. MILE continues to invite stakeholders, including patient associations, HCPs, pharmaceutical companies, regulators and national industry associations to engage and help advance these core principles for handling patient enquiries. This publication does not constitute legal advice; decision making and accountability remains with each pharmaceutical company.

Budget impact analysis of subcutaneous infliximab (CT-P13 SC) for treating inflammatory bowel disease in Saudi Arabia: Analysis from payer perspective.

The Saudi Food and Drug Authority (SFDA) has approved the subcutaneous (SC) administration of infliximab, presenting a more convenient alternative with reduced outpatient visits and diminished expenses compared to the intravenous (IV) administration. However, the financial implications of this formulation have not been examined from the perspective of Saudi payers. A prevalence-based budget impact model was developed to evaluate the financial effects of introducing "environment without" versus "with infliximab SC." The model's time horizon spanned over 2 years (2021-2023), aligning with the biennial national pharmaceutical procurement cycle. The comparison focused on infliximab SC versus all available formulations of infliximab IV in the Saudi market for two inflammatory bowel diseases (IBD): Ulcerative Colitis (UC) and Crohn's Disease (CD). Treatment comparators' comparability and dose escalations were substantiated by published studies, utilizing dosing information from the summary of product characteristics. Drug acquisition costs were derived from SFDA registered prices, with IV formulation administration costs included. Scenario analysis assessed the budget impact of infliximab SC introduction at uptake rates ranging from 0% to 100%. Introducing infliximab SC demonstrated cost-saving potential in the treatment of IBD. At 100% uptake with UC patients for 2 years, infliximab SC resulted in savings of -SAR-31.9 million (-SAR29,145 per patient). Similarly, for CD, introducing infliximab SC at 100% uptake over 2 years yielded savings of -SAR106.2 million (-SAR36,585 per patient). This study reveals that infliximab SC is associated with cost-saving potential when compared to infliximab IV formulations available in Saudi Arabia. Future research should address uncertainties related to real-world comparative effectiveness, the convenience of administration, patient tolerability, and physician acceptance of the SC formulation of infliximab, alongside comparisons with other TNF-alpha inhibitors.

Physicians' and pharmacists' perspective on clarity and clinical relevance of absolute contraindications in "Summaries of Product Characteristics".

Previous work has identified several limitations in "Summaries of Product Characteristics" (SmPCs), which are associated with risks for patients. The aim of this study was to evaluate pharmacists' and physicians' interpretation of contraindications in SmPCs and reasons for their nonadherence in clinical routine. For 20 commonly missed or ignored absolute contraindications, an anonymous online survey providing 24 clinical example cases (one or two per contraindication) for physicians and pharmacists was developed. Experts in medication safety were asked whether the respective case fulfilled the definition of the contraindication in the SmPC: (a) formally, irrespective of the clinical relevance of the contraindication (17 cases), and (b) whether the contraindication was deemed clinically relevant in each respective case (24 cases). Twenty-seven pharmacists and 27 physicians completed the survey. For only one case (1/17; 5.8%) did all experts agree on the same answer option regarding the formal fulfilment of a given contraindication statement. Experts gave heterogeneous answers regarding the interpretation of a contraindication. For instance, among 10 predefined answer options for the contraindication "active liver disease" in the SmPC of simvastatin, every option was selected by at least six experts. In 17/24 (70.8%) clinical example cases a majority of experts agreed on the clinical relevance of a given contraindication. Key reasons for nonadherence to contraindications were "patient monitoring possible", "lack of alternative treatment" and "acute/severe situations". Experts' disagreement on the interpretation of contraindications in SmPCs using clinical example cases indicates that further efforts are needed to improve their usability in clinical routine.

Artificial Intelligence Chatbots (ChatGPT and Google Gemini) Versus Traditional Patient Information Leaflets for Local Anesthesia in Eye Surgery: Correspondence.

Artificial Intelligence Chatbots (ChatGPT and Google Gemini) Versus Traditional Patient Information Leaflets for Local Anesthesia in Eye Surgery: Correspondence.

Circulation of COVID-19-Related Medicines on Japanese Websites during the COVID-19 Pandemic and Their Quality and Authenticity.

Substandard and falsified medical products for treating COVID-19 have spread worldwide. These medicines have entered Japan through personal importation of products purchased via the Internet. In this study, we investigated the circulation of 19 COVID-19-related medicines on the Internet in Japan and evaluated the pharmaceutical quality and authenticity of 2 medicines (dexamethasone tablets and ivermectin tablets) obtained online. We purchased 23 samples of 0.5-mg dexamethasone tablets and 13 samples of 3-mg ivermectin tablets from the Internet in December 2020 and July 2022. We investigated the quality and authenticity of the obtained samples through visual observation and tested their authenticity. We conducted pharmacopoeia compliance testing (quantitative assay, content uniformity tests, and dissolution tests) using the high-performance liquid chromatography-photodiode array detector method. No prescription was ever required at the time of purchase. Visual observation revealed that most samples lacked a package insert and some samples had packaging deficiencies. In terms of authenticity, eight ivermectin samples were genuine; the authenticity of the other samples remained uncertain. Four dexamethasone samples and three ivermectin samples failed quality testing based on pharmacopeia validation standards. Our findings illustrate that dexamethasone and ivermectin tablets of poor quality are available online. It is important to increase consumer awareness and provide information about these medicines to prevent the purchase of substandard medicines via the Internet.

Management of inoperable malignant bowel obstruction using the 4-step BOUNCED diet.

Malignant bowel obstruction (MBO) presents with multiple symptoms. The 4-step BOUNCED diet educates patients to self-manage oral intake according to symptoms. It includes clear fluids, thin liquids, purée and soft, sloppy foods, which are low in fibre. This mixed methods single-arm feasibility study aimed to establish if the diet could reduce MBO symptoms in patients with inoperable colorectal and gynaecological malignancies. The secondary objectives were to investigate if it was easily followed, improved quality of life (QOL) and reduced hospital admissions. Patients able to tolerate an oral diet with one or more symptoms (pain, bloating, early satiety, nausea and vomiting) were eligible. Following informed consent, an oncology dietitian took a diet history and determined which step of the diet they needed to follow using a detailed patient information leaflet. Patients remained on the trial for 28 days. Symptom and QOL data were collected on Days 1 and 28 using the Memorial Symptom Assessment Scale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) questionnaires. Thirty patients (24 female, 6 male) aged 18-85 years consented from March 2021 to November 2022. Twenty-six participants completed the trial and 25 found the diet very easy or easy to understand. There was a significant reduction in pain from 96% on Day 1 to 63% on Day 28 (p = 0.004). The mean increase of EORTC global health status/QOL was 23.5 points, 95% CI (12.4-32.5) (p ≤ 0.001). There was a significant difference between number of admissions (p = 0.018) and bed days (p = 0.004) in the 28 days prior to consent compared to the trial period. A modified consistency low-fibre diet is easily followed, may reduce symptoms of MBO, admissions to hospital and improve QOL.