Resistance training in advanced cancer: a phase II safety and feasibility trial—home versus hospital

2020 ◽  
pp. bmjspcare-2020-002230
Author(s):  
Catarina Ribeiro ◽  
Rui Santos ◽  
Pedro Correia ◽  
Matthew Maddocks ◽  
Barbara Gomes
Keyword(s):  
Resistance Training ◽  
Advanced Cancer ◽  
Phase Ii ◽  
Controlled Trial ◽  
Phase Iii ◽  
Feasibility Trial ◽  
Home Intervention ◽  
Randomised Controlled ◽  
Training Programmes ◽  
At Home

BackgroundResistance training (RT) is an effective way to increase muscle mass but little is known about its role to prevent sarcopenia in advanced cancer. Furthermore, the preferred setting for this training is not known. Considering home is frequently the place of care and death preferred by cancer patients, it is important to find out whether this would also be the best training setting as opposed to the most common one, hospital.ObjectivesWe aimed to test if RT at home and in hospital is feasible (primary outcome) and safe in advanced cancer, with a view to inform a phase III trial.MethodsPhase II randomised controlled trial including adults (≥18 years) with incurable solid tumours, randomised into one of three arms: (1) supervised RT at home; (2) supervised RT in hospital; (3) standard care with information leaflet. Both training programmes were similar, ran one-to-one with therapists and planned to last 12 weeks (three sessions/week). Feasibility included adherence (proportion of completed sessions) and acceptability (proportion of completed exercises), compared using Fisher’s test.ResultsWe included 15 patients (53% men, median age 68), 5 per arm. The home intervention had higher adherence (49% vs 9% in hospital; p<0.001). Acceptability was similar (93% in home and 95% in hospital; p=0.179). No adverse events were recorded.ConclusionsRT is a safe intervention, more feasible at home than in hospital in advanced cancer. Ways to increase adherence to the home intervention could further improve its potential benefit.Trial registration numberNCT02930876.

scholarly journals Children’s Oxygen Administration Strategies And Nutrition Trial (COAST-Nutrition): a protocol for a phase II randomised controlled trial

2021 ◽  
Vol 6 ◽  
pp. 221
Author(s):  
Sarah Kiguli ◽  
Peter Olopot-Olupot ◽  
Florence Alaroker ◽  
Charles Engoru ◽  
Robert O. Opoka ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Phase Ii ◽  
Nutritional Support ◽  
Cell Function ◽  
Action Plan ◽  
Controlled Trial ◽  
Severe Pneumonia ◽  
Phase Iii ◽  
Randomised Controlled ◽  
Usual Diet

Background: To prevent poor long-term outcomes (deaths and readmissions) the integrated global action plan for pneumonia and diarrhoea recommends under the ‘Treat’ element of Protect, Prevent and Treat interventions the importance of continued feeding but gives no specific recommendations for nutritional support. Early nutritional support has been practiced in a wide variety of critically ill patients to provide vital cell substrates, antioxidants, vitamins, and minerals essential for normal cell function and decreasing hypermetabolism. We hypothesise that the excess post-discharge mortality associated with pneumonia may relate to the catabolic response and muscle wasting induced by severe infection and inadequacy of the diet to aid recovery. We suggest that providing additional energy-rich, protein, fat and micronutrient ready-to-use therapeutic feeds (RUTF) to help meet additional nutritional requirements may improve outcome. Methods: COAST-Nutrition is an open, multicentre, Phase II randomised controlled trial in children aged 6 months to 12 years hospitalised with suspected severe pneumonia (and hypoxaemia, SpO2 <92%) to establish whether supplementary feeds with RUTF given in addition to usual diet for 56-days (experimental) improves outcomes at 90-days compared to usual diet alone (control). Primary endpoint is change in mid-upper arm circumference (MUAC) at 90 days and/or as a composite with 90-day mortality. Secondary outcomes include anthropometric status, mortality, readmission at days 28 and 180. The trial will be conducted in four sites in two countries (Uganda and Kenya) enrolling 840 children followed up to 180 days. Ancillary studies include cost-economic analysis, molecular characterisation of bacterial and viral pathogens, evaluation of putative biomarkers of pneumonia, assessment of muscle and fat mass and host genetic studies.   Discussion: This study is the first step in providing an option for nutritional support following severe pneumonia and will help in the design of a large Phase III trial. Registration: ISRCTN10829073 (6th June 2018) PACTR202106635355751 (2nd June 2021)

scholarly journals Feasibility of a multicentre, randomised controlled trial of laparoscopic versus open colorectal surgery in the acute setting: the LaCeS feasibility trial protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e018618 ◽  
Author(s):  
Deena Harji ◽  
Helen Marshall ◽  
Katie Gordon ◽  
Hannah Crow ◽  
Victoria Hiley ◽  
...  
Keyword(s):  
Laparoscopic Surgery ◽  
Randomised Controlled Trial ◽  
Colorectal Surgery ◽  
Controlled Trial ◽  
Phase Iii ◽  
Feasibility Trial ◽  
Complication Rates ◽  
Acute Setting ◽  
Patient Reported ◽  
Randomised Controlled

IntroductionAcute colorectal surgery forms a significant proportion of emergency admissions within the National Health Service. There is limited evidence to suggest minimally invasive surgery may be associated with improved clinical outcomes in this cohort of patients. Consequently, there is a need to assess the clinical effectiveness and cost-effectiveness of laparoscopic surgery in the acute colorectal setting. However,emergency colorectal surgical trials have previously been difficult to conduct due to issues surrounding recruitment and equipoise. The LaCeS (randomised controlled trial of Laparoscopic versus open Colorectal Surgery in the acute setting) feasibility trial will determine the feasibility of conducting a definitive, phase III trial of laparoscopic versus open acute colorectal resection.Methods and analysisThe LaCeS feasibility trial is a prospective, multicentre, single-blinded, parallel group, pragmatic randomised controlled feasibility trial. Patients will be randomised on a 1:1 basis to receive eitherlaparoscopic or open surgery. The trial aims to recruit at least 66 patients from five acute general surgical units across the UK. Patients over the age of 18 with a diagnosis of acute colorectal pathology requiring resection on clinical and radiological/endoscopic investigations, with a National Confidential Enquiry into Patient Outcome and Death classification of urgent will be considered eligible for participation. The primary outcome is recruitment. Secondary outcomes include assessing the safety profile of laparoscopic surgery using intraoperative and postoperative complication rates, conversion rates and patient-safety indicators as surrogate markers. Clinical and patient-reported outcomes will also be reported. The trial will contain an embedded qualitative study to assess clinician and patient acceptability of trial processes.Ethics and disseminationThe LaCeS feasibility trial is approved by the Yorkshire and The Humber, Bradford Leeds Research Ethics Committee (REC reference: 15/ YH/0542). The results from the trial will be presented at national and international colorectal conferences and will be submitted for publication to peer-reviewed journals.Trial registration numberISRCTN15681041; Pre-results.

scholarly journals Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e035947
Author(s):  
Sarah Brown ◽  
Jane Nixon ◽  
Myka Ransom ◽  
Rachael Gilberts ◽  
Nikki Dewhirst ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Phase Ii ◽  
Treatment Strategy ◽  
Controlled Trial ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Primary Objective ◽  
Phase Iii ◽  
Randomised Controlled ◽  
Post Randomisation

IntroductionDiabetes affects more than 425 million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of infection and ischaemia, optimising glycaemic control; use of advanced adjuvant therapies is limited by high cost and lack of robust evidence.Methods and analysisA multicentre, seamless phase II/III, open, parallel group, multi-arm multi-stage randomised controlled trial in patients with a hard-to-heal DFU, with blinded outcome assessment. A maximum of 447 participants will be randomised (245 participants in phase II and 202 participants in phase III). The phase II primary objective will determine the efficacy of treatment strategies including hydrosurgical debridement ± decellularised dermal allograft, or the combination with negative pressure wound therapy, as an adjunct to treatment as usual (TAU), compared with TAU alone, with patients randomised in a 1:1:1:2 allocation. The outcome is achieving at least 50% reduction in index ulcer area at 4 weeks post randomisation.The phase III primary objective will determine whether one treatment strategy, continued from phase II, reduces time to healing of the index ulcer compared with TAU alone, with participants randomised in a 1:1 allocation. Secondary objectives will compare healing status of the index ulcer, infection rate, reulceration, quality of life, cost-effectiveness and incidence of adverse events over 52 weeks post randomisation. Phase II and phase III primary endpoint analysis will be conducted using a mixed-effects logistic regression model and Cox proportional hazards regression, respectively. A within-trial economic evaluation will be undertaken; the primary economic analysis will be a cost-utility analysis presenting ICERs for each treatment strategy in rank order of effectiveness, with effects expressed as quality-adjusted life years.The trial has predefined progression criteria for the selection of one treatment strategy into phase III based on efficacy, safety and costs at 4 weeks.Ethics and disseminationEthics approval has been granted by the National Research Ethics Service (NRES) Committee Yorkshire and The Humber - Bradford Leeds Research Ethics Committee; approved 26 April 2017; (REC reference: 17/YH/0055). There is planned publication of a monograph in National Institute for Health Research journals and main trial results and associated papers in high-impact peer-reviewed journals.Trial registration numberISRCTN64926597; registered on 6 June 2017

scholarly journals Children’s Oxygen Administration Strategies And Nutrition Trial (COAST-Nutrition): a protocol for a phase II randomised controlled trial

2021 ◽  
Vol 6 ◽  
pp. 221
Author(s):  
Sarah Kiguli ◽  
Peter Olopot-Olupot ◽  
Florence Alaroker ◽  
Charles Engoru ◽  
Robert O. Opoka ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Phase Ii ◽  
Nutritional Support ◽  
Cell Function ◽  
Action Plan ◽  
Controlled Trial ◽  
Severe Pneumonia ◽  
Phase Iii ◽  
Randomised Controlled ◽  
Usual Diet

Background: To prevent poor long-term outcomes (deaths and readmissions) the integrated global action plan for pneumonia and diarrhoea recommends under the ‘Treat’ element of Protect, Prevent and Treat interventions the importance of continued feeding but gives no specific recommendations for nutritional support. Early nutritional support has been practiced in a wide variety of critically ill patients to provide vital cell substrates, antioxidants, vitamins, and minerals essential for normal cell function and decreasing hypermetabolism. We hypothesise that the excess post-discharge mortality associated with pneumonia may relate to the catabolic response and muscle wasting induced by severe infection and inadequacy of the diet to aid recovery. We suggest that providing additional energy-rich, protein, fat and micronutrient ready-to-use therapeutic feeds (RUTF) to help meet additional nutritional requirements may improve outcome. Methods: COAST-Nutrition is an open, multicentre, Phase II randomised controlled trial in children aged 6 months to 12 years hospitalised with suspected severe pneumonia (and hypoxaemia, SpO2 <92%) to establish whether supplementary feeds with RUTF given in addition to usual diet for 56-days (experimental) improves outcomes at 90-days compared to usual diet alone (control). Primary endpoint is change in mid-upper arm circumference (MUAC) at 90 days and/or as a composite with 90-day mortality. Secondary outcomes include anthropometric status, mortality, readmission at days 28 and 180. The trial will be conducted in four sites in two countries (Uganda and Kenya) enrolling 840 children followed up to 180 days. Ancillary studies include cost-economic analysis, molecular characterisation of bacterial and viral pathogens, evaluation of putative biomarkers of pneumonia, assessment of muscle and fat mass and host genetic studies.   Discussion: This study is the first step in providing an option for nutritional support following severe pneumonia and will help in the design of a large Phase III trial. Registration: ISRCTN10829073 (6th June 2018) PACTR202106635355751 (2nd June 2021)

scholarly journals Multicomponent non-pharmacological intervention to prevent delirium for hospitalised people with advanced cancer: study protocol for a phase II cluster randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e026177 ◽  
Author(s):  
Annmarie Hosie ◽  
Jane Phillips ◽  
Lawrence Lam ◽  
Slavica Kochovska ◽  
Beverly Noble ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Phase Ii ◽  
Controlled Trial ◽  
Phase Iii ◽  
Pharmacological Intervention ◽  
Phase Iii Trial ◽  
Prevention Intervention ◽  
Cluster Randomised ◽  
Hospitalised Patients ◽  
Delirium Prevention

IntroductionDelirium is a significant medical complication for hospitalised patients. Up to one-third of delirium episodes are preventable in older inpatients through non-pharmacological strategies that support essential human needs, such as physical and cognitive activity, sleep, hydration, vision and hearing. We hypothesised that a multicomponent intervention similarly may decrease delirium incidence, and/or its duration and severity, in inpatients with advanced cancer. Prior to a phase III trial, we aimed to determine if a multicomponent non-pharmacological delirium prevention intervention is feasible and acceptable for this specific inpatient group.Methods and analysisThe study is a phase II cluster randomised wait-listed controlled trial involving inpatients with advanced cancer at four Australian palliative care inpatient units. Intervention sites will introduce delirium screening, diagnostic assessment and a multicomponent delirium prevention intervention with six domains of care: preserving natural sleep; maintaining optimal vision and hearing; optimising hydration; promoting communication, orientation and cognition; optimising mobility; and promoting family partnership. Interdisciplinary teams will tailor intervention delivery to each site and to patient need. Control sites will first introduce only delirium screening and diagnosis, later implementing the intervention, modified according to initial results. The primary outcome is adherence to the intervention during the first seven days of admission, measured for 40 consecutively admitted eligible patients. Secondary outcomes relate to fidelity and feasibility, acceptability and sustainability of the study intervention, processes and measures in this patient population, using quantitative and qualitative measures. Delirium incidence and severity will be measured to inform power calculations for a future phase III trial.Ethics and disseminationEthical approval was obtained for all four sites. Trial results, qualitative substudy findings and implementation of the intervention will be submitted for publication in peer-reviewed journals, and reported at conferences, to study sites and key peak bodies.Trial registration numberACTRN12617001070325; Pre-results.

scholarly journals How is best supportive care provided in clinical trials for patients with advanced cancer? A review of registered protocols of clinical trials

2019 ◽  
Vol 27 (2) ◽  
Author(s):  
Á. Sanz Rubiales ◽  
M. E. Sánchez-Gutiérrez ◽  
L. A. Flores Pérez ◽  
M. L. Del Valle Ribero
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Best Supportive Care ◽  
Phase Iii ◽  
Consensus Statements ◽  
Definition Of ◽  
Randomised Controlled ◽  
Clinical Trials Registry

Background In 2012, 11 standards describing best supportive care (bsc) in clinical trials in advanced cancer were defined through consensus statements. The consensus included 15 key components. Our objective was to analyze whether clinical trials that involved patients with advanced cancer and that included bsc in at least 1 arm met the standards and contained the key components. Methods We reviewed clinical trials registered in ClinicalTrials.gov, the isrctn (International Standard Randomised Controlled Trial Number) registry, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform for 2012–2018. We selected only phase iii studies in patients with advanced cancer that included bsc in at least 1 arm. We describe the characteristics of the trials, together with the definition and components of bsc. We analyzed how the trials met the standards and adopted the key components of bsc. Results Of 193 trials retrieved, only 64 met the inclusion criteria; 36 of those trials (56%) had no definition of bsc. Less than 7% of the trials included even 3 of the 8 bsc standards that were defined to be included in the design of trials. Furthermore, trials mentioned only 5 of the 15 key components that the consensus defined to be fundamental, with symptom management appearing in 22% of trials and the other 4 components appearing in less than 8%. Summary Most clinical trials registered during 2012–2018 that involved patients with cancer and an arm with bsc did not define the bsc concept. Hence, the design of those trials does not meet the consensus recommendations.

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