REVOLUTION Surgery (REVOLUTION Surgery)

NCT ID: NCT05642819

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Cachexia; Oesophageal Cancer; Gastric Cancer; Pancreatic Cancer; Colorectal Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard JE Skipworth, MD FRCS

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh / NHS Lothian

Locations

University of Edinburgh

Edinburgh, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Richard JE Skipworth, MD FRCS

Role: CONTACT

Richard.Skipworth@nhslothian.scot.nhs.uk

01312423176

Leo R Brown, MBChB MRCS

Role: CONTACT

leorbrown@doctors.org.uk

01312423614

Facility Contacts

Richard JE Skipworth, MD FRCS

Role: primary

richard.skipworth@nhslothian.scot.nhs.uk

01312423176

Other Identifiers

AC22098

Identifier Type: -

Identifier Source: org_study_id