REVOLUTION Surgery (REVOLUTION Surgery)

Trial Title: REVOLUTION Surgery (REVOLUTION Surgery)

NCT ID: NCT05642819

Condition: Cachexia
Oesophageal Cancer
Gastric Cancer
Pancreatic Cancer
Colorectal Cancer

Conditions: Official terms:
Cachexia

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

Study pop:
Patients planned for surgical resection of a gastrointestinal tract cancer, at risk of cancer cachexia, recruited from surgical services in the UK.

Sampling method: Non-Probability Sample
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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Locations:

Facility:
Name: University of Edinburgh

Address:
City: Edinburgh
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Richard JE Skipworth, MD FRCS

Phone: 01312423176
Email: richard.skipworth@nhslothian.scot.nhs.uk

Investigator:
Last name: Richard JE Skipworth, MD FRCS
Email: Principal Investigator

Investigator:
Last name: Leo R Brown, MBChB MRCS
Email: Sub-Investigator

Start date: October 1, 2023

Completion date: December 2027

Lead sponsor:
Agency: University of Edinburgh
Agency class: Other

Collaborator:
Agency: NHS Lothian
Agency class: Other

Source: University of Edinburgh

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05642819