An observational study in Cachexia, Oesophageal Cancer and Gastric Cancer, sponsored by University of Edinburgh. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by University of Edinburgh · Observational
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.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 88 observational studies indexed under Cachexia.
Browse Cachexia studies →University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients planned for surgical resection of a gastrointestinal tract cancer, at risk of cancer cachexia, recruited from surgical services in the UK.
Inclusion Criteria:
Inclusion Criteria (Cancer Resection)
Inclusion Criteria (Healthy Controls)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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
Longitudinal changes in weight
Longitudinal changes in weight (kg) - combined with height (m) to report body mass index (BMI) (kg/m2)
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 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.
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 CT body composition (muscle radiodensity)
Longitudinal changes in radiodensity (HU - Hounsfield units) of skeletal muscle
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 CT body composition (fat quantity)
Longitudinal changes in cross-sectional area (cm2) and volume (cm3) of subcutaneous and visceral adipose tissue
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 CT body composition (fat radiodensity)
Longitudinal changes in radiodensity (HU - Hounsfield units) of subcutaneous and visceral adipose tissue
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 systemic inflammation
Longitudinal changes in serum levels of pro-inflammatory cytokines and other markers of 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 physical activity
A personal activity monitor (FitBit) will be worn for the next eight days to assess step count and time of 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
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
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 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.
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 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
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 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
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 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
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 tissue-level changes in fat content
Longitudinal changes in tissue level changes associated with cachexia, such as fat content of skeletal muscle
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 tissue-level changes in collagen content
Longitudinal changes in tissue level changes associated with cachexia, such as collagen content of skeletal muscle
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 tissue-level changes in protein content
Longitudinal changes in tissue level changes associated with cachexia, such as protein content of skeletal muscle
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
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
Time frame: MRI scan performed pre-operatively
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.
Time frame: 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.
Time frame: MRI scan and assessments of physical function & muscle strength performed pre-operatively.
Plan to share: Undecided — To be confirmed
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