NCT05642819 REVOLUTION Surgery (REVOLUTION Surgery)
| NCT ID | NCT05642819 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Cachexia |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-10-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
Richard JE Skipworth, MD FRCS
PRINCIPAL INVESTIGATOR
University of Edinburgh / NHS Lothian
Frequently Asked Questions
Who can join the NCT05642819 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cachexia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05642819 currently recruiting?
Yes, NCT05642819 is actively recruiting participants. Contact the research team at Richard.Skipworth@nhslothian.scot.nhs.uk for enrollment information.
Where is the NCT05642819 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom.
Who is sponsoring the NCT05642819 clinical trial?
NCT05642819 is sponsored by University of Edinburgh. The principal investigator is Richard JE Skipworth, MD FRCS at University of Edinburgh / NHS Lothian. The trial plans to enroll 200 participants.