Clinical trial NCT05642819: REVOLUTION Surgery (REVOLUTION Surgery)
Official title: Routine Evaluation of People Living With Cancer - Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cachexia
Oesophageal Cancer
Gastric Cancer
Pancreatic Cancer
Colorectal Cancer
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2022-12-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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)

Primary outcomes:
measure: Longitudinal changes in weight
timeFrame: 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
measure: Longitudinal changes in computed tomography (CT) body composition (muscle quantity)
timeFrame: 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
measure: Longitudinal changes in CT body composition (muscle radiodensity)
timeFrame: 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
measure: Longitudinal changes in CT body composition (fat quantity)
timeFrame: 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
measure: Longitudinal changes in CT body composition (fat radiodensity)
timeFrame: 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
measure: Longitudinal changes in systemic inflammation
timeFrame: 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
measure: Longitudinal changes in physical activity
timeFrame: 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
measure: Longitudinal changes in muscle function
timeFrame: 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
measure: Longitudinal changes in muscle strength
timeFrame: 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
measure: Longitudinal changes in risk of nutritional deficit
timeFrame: 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
measure: Longitudinal changes in quality of life (physical, psychological and social function in patients with cancer)
timeFrame: 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
measure: Longitudinal changes in symptom burden, function and general quality of life in patients with anorexia / cachexia)
timeFrame: 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
measure: Longitudinal tissue-level changes in fat content
timeFrame: 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
measure: Longitudinal tissue-level changes in collagen content
timeFrame: 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
measure: Longitudinal tissue-level changes in protein content
timeFrame: 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
measure: Evaluation of multiparametric magnetic resonance imaging (MRI) in cachexia
timeFrame: MRI scan performed pre-operatively
Secondary outcomes:
measure: Correlation of multiparametric magnetic resonance imaging (MRI) and tissue-level changes
timeFrame: MRI scan performed pre-operatively, tissue samples collected at the point of surgical resection.
measure: Correlation of multiparametric magnetic resonance imaging (MRI) and changes in physical function
timeFrame: MRI scan and assessments of physical function & muscle strength performed pre-operatively.
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
Study officials:
affiliation: University of Edinburgh / NHS Lothian
name: Richard JE Skipworth, MD FRCS
role: PRINCIPAL_INVESTIGATOR
References: