Cancer patients are often malnourished pre-operatively. The present study aimed to establish whether current screening was appropriate for use in prehabilitation and investigate any association between nutritional risk, functionality and quality of life (QoL).This cohort study used routinely collected data from September 2020 to August 2021 from patients in a Prehab4cancer programme. Included patients were aged ≥ 18 years, had colorectal, lung or oesophago-gastric cancer and were scheduled for surgery. Nutritional assessment included Patient-Generated Subjective Global Assessment (PG-SGA) Short-Form and QoL with a sit-to-stand test. Association between nutritional risk and outcomes was analysed using adjusted logistic regression.From 928 patients referred to Prehab4Cancer service over 12 months, data on nutritional risk were collected from 526 patients. Pre-operatively, 233 out of 526 (44%) patients were at nutritional risk (score ≥ 2). During prehabilitation, 31% of patients improved their PG-SGA and 74% of patients maintained or improved their weight. Odds ratios (OR) with confidence intervals (CI) showed that patients with better QoL using EuroQol-5 Dimensions (OR = 0.05, 95% CI = 0.01, 0.45, p = 0.01), EuroQol Visual Analogue Scale (OR = 0.96, 95% CI = 0.93, 1.00, p = 0.04) or sit-to-stand (OR = 0.96, 95% 0.93, 1.00, p = 0.04) were less likely to be nutritional at risk.Almost half of patients in Prehab4Cancer programme assessed using PG-SGA were at risk of malnutrition. However, almost half of the sample did not have their risk assessed. Patients at risk of malnutrition were more likely to have a poorer QoL and sit-to-stand test than those who were not at risk.
Introduction Patients receiving radiotherapy are at risk of developing radiotherapy-related insufficiency fractures, which are associated with increased morbidity and pose a significant burden to patients’ quality of life and to the health system. Therefore, effective preventive techniques are urgently required. The RadBone randomised controlled trial (RCT) aims to determine the feasibility and acceptability of a musculoskeletal health package (MHP) intervention in women undergoing pelvic radiotherapy for gynaecological malignancies and to preliminary explore clinical effectiveness of the intervention. Methods and analysis The RadBone RCT will evaluate the addition to standard care of an MHP consisting of a physical assessment of the musculoskeletal health, a 3-month prehabilitation personalised exercise package, as well as an evaluation of the fracture risk and if required the prescription of appropriate bone treatment including calcium, vitamin D and—for high-risk individuals—bisphosphonates. Forty participants will be randomised in each group (MHP or observation) and will be followed for 18 months. The primary outcome of this RCT will be feasibility, including the eligibility, screening and recruitment rate, intervention fidelity and attrition rates; acceptability and health economics. Clinical effectiveness and bone turnover markers will be evaluated as secondary outcomes. Ethics and dissemination This study has been approved by the Greater Manchester East Research Ethics Committee (Reference: 20/NW/0410, November 2020). The results will be published in peer-reviewed journals, will be presented in national and international conferences and will be communicated to relevant stakeholders. Moreover, a plain English report will be shared with the study participants, patients’ organisations and media. Trial registration number NCT04555317 .
Malignant Pleural Mesothelioma (MPM) is associated with high symptom burden, cancer cachexia and poor health-related quality of life (HRQOL), even in those with good performance status (PS). Improving and maintaining HRQOL is a key goal in MPM management, and maximising systemic anti-cancer treatment (SACT) opportunity has never been more important. However, SACT uptake is typically low, often due to reduced physical fitness associated with MPM and advanced age at diagnosis. Exercise therapy is a rational approach to improving HRQOL and could maintain and/or improve fitness. There is evidence to support exercise therapy in other cancers, but there is limited evidence for the role of exercise therapy in MPM. EXTRA-Meso feasibility study is a prospective, randomised feasibility trial of exercise therapy versus standard care in patients with a diagnosis of MPM.
Methods
EXTRA-Meso Feasibility is currently recruiting from two UK centres (Glasgow and Manchester). Patients with a diagnosis of mesothelioma, ratified by a mesothelioma MDT; PS 0 - 2; clinical frailty score ≤5 and able/willing to provide informed written consent are eligible. Patients will be randomised 1:1 to intervention, where they receive a 12 week personalised exercise programme, after being assessed by a physiotherapist or qualified exercise professional with specific cancer training, or standard care (routine clinical follow-up). Baseline and follow-up assessments include functional fitness assessments and HRQOL questionnaires. Study flowchart is detailed in figure 1. The primary objective is to determine whether it is feasible to recruit and randomise 40 patients within 12 months. Secondary objectives include assessment of barriers to study recruitment and retention, and to determine the safety and tolerability of the exercise intervention and study assessments.
Results
The study opened to recruitment on 18th January 2024, at the time of submission 19/40 patients had been enrolled and randomised. Preliminary results relating to study secondary objectives will be available for presentation at BTS Winter Meeting 2024.
Conclusion
Results of EXTRA-Meso feasibility will directly influence the study design of a future phase 3 randomised trial. Recruitment to date has met target recruitment rate, and if the current rate continues, a phase 3 study is likely to be feasible.