REVOLUTION Surgery (REVOLUTION Surgery)

Official title

Routine Evaluation of People Living With Cancer - Surgery

Overview

Some people with cancer suffer from muscle wasting, lose weight and feel tired. This process, termed cachexia, is a significant problem and can lead to a reduction in both quality and quantity of life. Cachexia is caused by interactions between the tumour and the patient. Historically, it was considered to be a purely end-stage phenomenon of advanced cancer, however, it is now known that early signs of cachexia can even influence the outcomes of patients with potentially curative pathology, including those planned for a surgical resection. This study aims to collect information, from patients who are at risk of cachexia, about body composition, physical activity, quality of life and the body's immune response to cancer. Previously these measures have been most frequently studied in isolation, or at one single time-point, and are therefore likely to give an incomplete picture. A more holistic characterisation of surgical patients at risk of cancer cachexia, across their treatments, is currently lacking. Participants with cancer will be recruited to the study from surgical services in the United Kingdom (UK). A small number of 'control' patients without cancer, who are undergoing surgery for a benign condition, will also be recruited for comparison. Those recruited will have their height and weight measured, answer questionnaires about quality of life, undergo assessment of their physical function and levels of activity, have blood taken to analyse markers of inflammation and have their body composition measured by a variety of methods. A subgroup of patients will also undergo an additional magnetic resonance imaging (MRI) scan of their abdomen and thighs. At the time of their operation, participants will also have small biopsies of muscle, fat, tumour and urine taken for biochemical analysis. Patients with cancer, will be asked to return for three follow up appointments during the year after their operation where these assessments will be repeated.

Primary outcome measures

• Longitudinal changes in weight [Time frame: Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection]
• Longitudinal changes in computed tomography (CT) body composition (muscle quantity) [Time frame: Measured at staging CT scan, at repeat scan following any neoadjuvant anti-cancer therapies and at follow-up scans following surgical resection / adjuvant anti-cancer therapies and other scans up to 1 year post surgical resection]
• Longitudinal changes in CT body composition (muscle radiodensity) [Time frame: Measured at staging CT scan, at repeat scan following any neoadjuvant anti-cancer therapies and at follow-up scans following surgical resection / adjuvant anti-cancer therapies and other scans up to 1 year post surgical resection]
• Longitudinal changes in CT body composition (fat quantity) [Time frame: Measured at staging CT scan, at repeat scan following any neoadjuvant anti-cancer therapies and at follow-up scans following surgical resection / adjuvant anti-cancer therapies and other scans up to 1 year post surgical resection]
• Longitudinal changes in CT body composition (fat radiodensity) [Time frame: Measured at staging CT scan, at repeat scan following any neoadjuvant anti-cancer therapies and at follow-up scans following surgical resection / adjuvant anti-cancer therapies and other scans up to 1 year post surgical resection]
• Longitudinal changes in systemic inflammation [Time frame: Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection]
• Longitudinal changes in physical activity [Time frame: Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection]
• Longitudinal changes in muscle function [Time frame: Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection]
• Longitudinal changes in muscle strength [Time frame: Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection]
• Longitudinal changes in risk of nutritional deficit [Time frame: Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection]

Secondary outcome measures (2)

• Correlation of multiparametric magnetic resonance imaging (MRI) and tissue-level changes [Time frame: MRI scan performed pre-operatively, tissue samples collected at the point of surgical resection.]
• Correlation of multiparametric magnetic resonance imaging (MRI) and changes in physical function [Time frame: MRI scan and assessments of physical function & muscle strength performed pre-operatively.]

Eligibility criteria

Inclusion criteria

Inclusion Criteria (Cancer Resection)

• Patients with cancer (Clinical, histological, cytological or radiological evidence) planned for surgical resection of a malignancy of the oesophagus, stomach, pancreas, colon, or rectum
• Aged 18-years and over
• Able to give written informed consent

Inclusion Criteria (Healthy Controls)

• Patients identified at surgical clinic as being planned for an open abdominal operation for a non-inflammatory, benign condition (e.g. donor nephrectomy)
• Aged 18-years and over
• Able to give written informed consent

Exclusion criteria

• Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would increase the risk of complication for the participant and/or investigator
• Presence of a concomitant inflammatory (e.g., rheumatoid arthritis, inflammatory bowel disease) or muscle wasting condition other than cancer
• Participants who are pregnant, suffer from claustrophobia or with implanted medical devices (e.g., cardiac pacemaker, metallic foreign bodies, aneurysm clip) would not be able to undergo the additional multiparametric magnetic resonance imaging (MRI)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Other

Study locations

United Kingdom · 1 center

• University of Edinburgh — Edinburgh

Identifiers

NCT: NCT05642819 · AC22098

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗