REVOLUTION Surgery (REVOLUTION Surgery)

NCT05642819 | Recruiting

• 1 other identifier: AC22098
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (16)

• Longitudinal changes in weight

  Longitudinal changes in weight (kg) - combined with height (m) to report body mass index (BMI) (kg/m2)

  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)

  Longitudinal changes in cross-sectional area (cm2) and volume (cm3) of skeletal muscle and radiodensity of skeletal muscle, subcutaneous fat, visceral fat and intra-muscular adipose tissue.

  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)

  Longitudinal changes in radiodensity (HU - Hounsfield units) of skeletal muscle

  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)

  Longitudinal changes in cross-sectional area (cm2) and volume (cm3) of subcutaneous and visceral adipose tissue

  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)

  Longitudinal changes in radiodensity (HU - Hounsfield units) of subcutaneous and visceral adipose tissue

  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

  Longitudinal changes in serum levels of pro-inflammatory cytokines and other markers of systemic inflammation

  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

  A personal activity monitor (FitBit) will be worn for the next eight days to assess step count and time of physical activity

  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

  The 'timed up and go' test will be assessed for all participants as an estimate of lower limb muscle function

  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

  Isometric knee extension will be assessed for patients undergoing a multiparametric MRI as an estimate of quadriceps strength. This will be done using a hand-held dynamometer.

  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

  Patient Generated Subjective Global Assessment Short Form ('PG-SGA-SF') questionnaires will be used to assess symptom burden and quality of life measures, specifically regarding nutritional risk in catabolic conditions

  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 quality of life (physical, psychological and social function in patients with cancer)

  European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire C30 ('EORTC-QLQ-C30') questionnaires will be used to assess symptom burden and general quality of life

  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 symptom burden, function and general quality of life in patients with anorexia / cachexia)

  Functional Assessment of Anorexia / Cachexia Therapy ('FAACT') questionnaires will be used to assess symptom burden, quality of life and function

  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 tissue-level changes in fat content

  Longitudinal changes in tissue level changes associated with cachexia, such as fat content of skeletal muscle

  Muscle biopsies will be taken at the time of surgical resection. Where participants are amenable, additional repeat needle biopsies of the quadriceps muscle will be performed at follow-up appointments 6 (+/- 1) months and 12 (+/- 1) months post surgery

• Longitudinal tissue-level changes in collagen content

  Longitudinal changes in tissue level changes associated with cachexia, such as collagen content of skeletal muscle

  Muscle biopsies will be taken at the time of surgical resection. Where participants are amenable, additional repeat needle biopsies of the quadriceps muscle will be performed at follow-up appointments 6 (+/- 1) months and 12 (+/- 1) months post surgery

• Longitudinal tissue-level changes in protein content

  Longitudinal changes in tissue level changes associated with cachexia, such as protein content of skeletal muscle

  Muscle biopsies will be taken at the time of surgical resection. Where participants are amenable, additional repeat needle biopsies of the quadriceps muscle will be performed at follow-up appointments 6 (+/- 1) months and 12 (+/- 1) months post surgery

• Evaluation of multiparametric magnetic resonance imaging (MRI) in cachexia

  Evaluation of multiparametric MRI as a novel method for estimation of skeletal muscle mass and fat-infiltration across cachectic and weight-stable patients with cancer

  MRI scan performed pre-operatively

Secondary Outcomes (2)

• Correlation of multiparametric magnetic resonance imaging (MRI) and tissue-level changes

  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

  MRI scan and assessments of physical function & muscle strength performed pre-operatively.

Study Arms (2)

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

University of Edinburgh

Edinburgh, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples - approximately 40mls. Urine samples - approximately 20mls. Muscle samples - small sample Fat samples - small sample Tumour samples - small sample

MeSH Terms

Conditions

Cachexia; Esophageal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Richard JE Skipworth, MD FRCS

  University of Edinburgh / NHS Lothian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard JE Skipworth, MD FRCS

CONTACT

01312423176; Richard.Skipworth@nhslothian.scot.nhs.uk

Leo R Brown, MBChB MRCS

CONTACT

01312423614; leorbrown@doctors.org.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: December 8, 2022
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-12

Locations

GB (1)