SPECS v1.0
Research type
Research Study
Full title
A randomised controlled mechanistic trial comparing Standard care versus Prehabilitation in patients undergoing Elective hepatopancreatobiliary (HPB) and colorectal Cancer Surgery
IRAS ID
270710
Contact name
Joel Lambert
Contact email
Sponsor organisation
East Lancashire Healthcare Trust
Duration of Study in the UK
1 years, 2 months, 3 days
Research summary
Preliminary qualitative and quantitative studies suggest that there are benefits (reduced length of stay, improved cardiorespiratory function, reduced postoperative complications and improved quality of life) when prehabilitation is used with the context of cancer care. In 2017 Macmillian Cancer Support developed a strategic ’Evidence and Insight’ review on prehabilitation. The outcome of this was to incorporate prehabilitation into routine cancer care and to develop principles and guidance for prehabilitation. This study aims to support this vision and answer some of the questions on the patients who are most likely to benefit from prehabilitation and to quantify some of these benefits by investigating the molecular processes that influence clinical changes\n\nThis study primarily seeks to assess the impact of prehabilitation (exercise, nutrition) on metabolic markers (cytokines). These markers are thought to play a role in influencing some clinical outcomes such as wound infection. The study will also assess secondary outcomes including hospital stay, complications and quality of life. We aim to better understand the biological relationship between anti-inflammatory cytokine levels and the previously mentioned outcomes by measuring and analysing these mediators and performing selected muscle biopsies.\n\n\nAll patients undergoing colorectal and hepato-pancreatobiliary cancer surgery would be eligible. The aim is to recruit patients from multi-disciplinary team meetings with the support of local cancer care specialist teams. We intend to recruit from a cohort at East Lancashire Hospital Trust(ELHT). The study will be undertaken on different sites Clinical/Academic/Laboratory). The University of Lancashire will provide technical and academic support. The laboratory analyses will be performed at the biosciences laboratory at Lancaster University. Some of the exercise-related analyses will take place at the new ’state of the art’ human performance lab at Lancaster University. \n
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
20/YH/0266
Date of REC Opinion
22 Sep 2020
REC opinion
Unfavourable Opinion