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2023-10-01
2027-12
2027-12
200
NCT05642819
University of Edinburgh
University of Edinburgh
OBSERVATIONAL
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-09-15 | N/A | 2024-11-29 |
2022-11-29 | N/A | 2024-12-04 |
2022-12-08 | N/A | 2024-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Richard JE Skipworth, MD FRCS Phone Number: 01312423176 Email: Richard.Skipworth@nhslothian.scot.nhs.uk |
Study Contact Backup Name: Leo R Brown, MBChB MRCS Phone Number: 01312423614 Email: leorbrown@doctors.org.uk |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
