Sarcopenia and physiology assessments in cancer patients
Research type
Research Study
Full title
Assessment of measures of sarcopenia and whole body physiology in cancer patients and their relationship to surgical outcome and survival
IRAS ID
215694
Contact name
Malcolm West
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The proposed study is made up of two distinct work packages. We hypothesise that an objectively measured reduction in muscle mass (i.e. Computed Tomography (CT) measured indices of sarcopenia) coupled with reduced physical fitness (measured objectively using Cardiopulmonary Exercise Testing (CPET)) will result in worse post-operative surgical outcome and reduced survival in patients going straight to surgery or having cancer therapies.
Work package 1 proposes to analyse data already collected from NIHR Research for Patient Benefit (RfPB) and British Lung Foundation funded clinical trials (Sponsor – University Hospital Southampton NHS Foundation Trust held by the Fit-4-Surgery group), in an attempt to interrogate this hypothesis in patients pre- and post cancer treatment prior to upper and lower gastrointestinal surgery as well as in palliative lung cancer patients. Specifically we aim to interrogate the changes in sarcopenia and fitness markers with neoadjuvant chemotherapy (i.e. chemotherapy used before surgery), neoadjuvant chemoradiotherapy (i.e. chemoradiotherapy used before surgery) and palliative chemotherapy (i.e. chemotherapy given when surgical treatment is no longer an option) in an attempt to correlate these to post-operative clinical outcomes and/or survival. No other additional testing or patient contact is required. The total patient cohort to be analysed is 247 patients.
Work package 2 proposes an analyses of prospectively collected clinical data from routine clinical practice in a cohort of upper and lower gastrointestinal and hepatobiliary (liver, pancreas and biliary tree) cancer patients in an attempt to validate the above analyses prospectively. These patients may undergo neoadjuvant (before surgery) cancer therapies before undergoing surgery. No other additional testing or patient contact is required other then their routine clinical care. The total patient cohort to be recruited is 614 patients.
REC name
South East Scotland REC 02
REC reference
16/SS/0188
Date of REC Opinion
6 Dec 2016
REC opinion
Further Information Favourable Opinion