REVOLUTION Surgery (REVOLUTION Surgery)

Colorectal Cancer Clinical Trial

Official title:

Routine Evaluation of People Living With Cancer - Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642819
• Other study ID #: AC22098
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: University of Edinburgh
• Contact: Richard JE Skipworth, MD FRCS
• Phone: 01312423176
• Email: Richard.Skipworth[@]nhslothian.scot.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cachexia
• Colorectal Cancer
• Gastric Cancer
• Oesophageal Cancer
• Pancreatic Cancer

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Correlation of multiparametric magnetic resonance imaging (MRI) and tissue-level changes	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.	MRI scan performed pre-operatively, tissue samples collected at the point of surgical resection.
Secondary	Correlation of multiparametric magnetic resonance imaging (MRI) and changes in physical function	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.	MRI scan and assessments of physical function & muscle strength performed pre-operatively.