SPECS v2.0
Research type
Research Study
Full title
A mechanistic trial comparing Standard care versus Prehabilitation in patients undergoing Elective hepatopancreatobiliary (HPB) and colorectal Cancer Surgery: A feasibility study
IRAS ID
290723
Contact name
Joel Lambert
Contact email
Sponsor organisation
East Lancashire Hospitals NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 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.
This study has 2 main objectives:
• To investigate the cardiovascular responses to prehabilitation. This will be determined by measuring improvements in anaerobic threshold and peak oxygen consumption.
• To investigate the biological responses to prehabilitation. This will be determined by analysing the types and amounts of circulatory inflammatory cytokines in skeletal muscle and blood.
All 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. Lancaster University 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 human performance lab at Lancaster University.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0069
Date of REC Opinion
26 Apr 2021
REC opinion
Further Information Favourable Opinion