REVOLUTION Surgery (REVOLUTION Surgery)

Last updated: November 29, 2024
Sponsor: University of Edinburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Gastric Cancer

Pancreatic Cancer

Treatment

N/A

Clinical Study ID

NCT05642819
AC22098
  • Ages > 18
  • All Genders

Study 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

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 abdominaloperation for a non-inflammatory, benign condition (e.g. donor nephrectomy)

  • Aged 18-years and over

  • Able to give written informed consent

Exclusion

Exclusion Criteria:

  • Any concomitant medical or psychiatric problems which, in the opinion of theinvestigator, would increase the risk of complication for the participant and/orinvestigator

  • Presence of a concomitant inflammatory (e.g., rheumatoid arthritis, inflammatorybowel disease) or muscle wasting condition other than cancer

  • Participants who are pregnant, suffer from claustrophobia or with implanted medicaldevices (e.g., cardiac pacemaker, metallic foreign bodies, aneurysm clip) would notbe able to undergo the additional multiparametric magnetic resonance imaging (MRI)

Study Design

Total Participants: 200
Study Start date:
October 01, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • University of Edinburgh

    Edinburgh,
    United Kingdom

    Active - Recruiting

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