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NCT Number: NCT05642819

REVOLUTION Surgery (REVOLUTION Surgery)

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Edinburgh

Edinburgh, United Kingdom

Location status: Recruiting

Location contact

Leo R Brown, MBChB MRCS

SUB_INVESTIGATOR

Richard JE Skipworth, MD FRCS

CONTACT

[email protected]

01312423176

Richard JE Skipworth, MD FRCS

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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 weight (kg) - combined with height (m) to report body mass index (BMI) (kg/m2)

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

  3. 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 radiodensity (HU - Hounsfield units) of skeletal muscle

  4. 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 cross-sectional area (cm2) and volume (cm3) of subcutaneous and visceral adipose tissue

  5. 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 radiodensity (HU - Hounsfield units) of subcutaneous and visceral adipose tissue

  6. 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 serum levels of pro-inflammatory cytokines and other markers of systemic inflammation

  7. 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

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

  8. 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

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

  9. 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

    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.

  10. 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

    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

  11. Longitudinal changes in quality of life (physical, psychological and social function in patients with cancer)

    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

    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

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

    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

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

  13. Longitudinal tissue-level changes in fat content

    Time frame: 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 changes in tissue level changes associated with cachexia, such as fat content of skeletal muscle

  14. Longitudinal tissue-level changes in collagen content

    Time frame: 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 changes in tissue level changes associated with cachexia, such as collagen content of skeletal muscle

  15. Longitudinal tissue-level changes in protein content

    Time frame: 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 changes in tissue level changes associated with cachexia, such as protein content of skeletal muscle

  16. Evaluation of multiparametric magnetic resonance imaging (MRI) in cachexia

    Time frame: MRI scan performed pre-operatively

    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

Secondary outcomes

  1. 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 MRI estimates of skeletal muscle mass and fat infiltration with CT image derived analyses and tissue level changes in fat, collagen and protein content of skeletal muscle.

  2. 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.

    Evaluation of the relationship between physical function & muscle strength (as assessed by personal activity monitor (FitBit), 'timed up and go' test and isometric knee extension using a hand-held dynamometer) and multiparametric MRI assessment of thigh muscle quantity.

Study contacts

Contact information is provided by the study sponsor or research team.

Leo R Brown, MBChB MRCS

CONTACT

[email protected]

01312423614

Richard JE Skipworth, MD FRCS

CONTACT

[email protected]

01312423176

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

Routine Evaluation of People Living With Cancer - Surgery

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2022
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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