RecruitingNCT06112964

Neurobehavioural and Cognitive Changes in Cancer Cachexia (CANCOG)

Understanding the Impact on CANcer on Neurobehavioral Mechanisms and COGnition in Cachexia (CANCOG)


Sponsor

University of Cambridge

Enrollment

50 participants

Start Date

Feb 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to to look for changes within the brain, and changes in body-to-brain signals in people with cancer and people who do not have cancer. The main questions it aims to answer are: 1. Are there differences in areas of the brain known to be related to appetite control, food reward and motivation, between participants with cancer related weight loss and healthy volunteers 2. Do responses to questionnaires and computer based tasks suggest participants with cancer related weight loss have reduced appetite and reduced motivation to eat compared to healthy volunteers, and if so, do questionnaires suggest that this is associated with any other symptoms? Researchers will compare the structure and blood flow in relevant areas of the brain using MRI images between participants with cancer related weight loss and healthy volunteers. Participants will complete questionnaires and computer based tasks to allow researchers to assess areas of the brain which become more active in response to different stimuli. Some computer based tasks will be performed during the MRI scan. This is called functional MRI. A further objective is to obtain an archive of blood samples which will be stored securely for future analysis if relevant hormones or analytes are identified that may be relevant to metabolism or body composition


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Written informed consent
  • Aged 18 years or over
  • Willing and able to comply with study procedures and visits
  • Histological or cytological diagnosis of cancer or confirmed non-intracranial malignancy on imaging.
  • Unintended documented weight loss of >5% body weight in 6 months which is felt to be cancer related, OR patient reported weight loss and/or change in appetite

Exclusion Criteria13

  • Non-fluent English speaker
  • Active infection, as determined by the investigator based on clinical symptoms and / or fever and / or requirement for antibiotics
  • Women, who are pregnant, plan to become pregnant or are lactating.
  • MRI contraindication
  • A significant acute, chronic or psychiatric condition which in the judgement of the investigator would place the volunteer at undue risk or interfere with the study
  • Metabolically or clinically unstable on day of study visit
  • Artificial nutrition
  • Taking medications which, as determined by the investigator, may affect appetite or cognition, or otherwise affect completion of study tasks.
  • Weight or body circumference above upper threshold for MRI scanner (220kg)
  • Unresolved obstructive gastrointestinal (GI) lesion
  • Intracranial cancer or metastatic intracranial involvement of cancer
  • Have, or be recovering from, any form of cancer
  • Unintentional weight loss of >5% body weight or unexplained loss of appetite

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Interventions

PROCEDUREMRI/ Functional MRI

Participants will undergo an MRI scan lasting approximately 1 hour to examine the structure and function of the brain. During the scan, they will also be asked to perform computer based tasks. This is called functional MRI.

BEHAVIORALSelf-reported questionnaires

Participants will complete questionnaires covering subjective measures relating to food attitudes and intake, and report-based measures of relevant psychopathology including depression and anxiety. These will be derived from standardised scales already used clinically, including the setting of eating disorders and normative studies of the neuroscience of appetite.

BEHAVIORALComputer based tasks

Participants will complete computer based tasks which are focused specifically on aspects of appetite-related and reward behaviours. Typically, such behaviours are characterised under the following sub-headings: i) Motivation (the amount of effort, cognitive or physical, that a person is prepared to expend in order to gain access to food), ii) Valuation (the relative rating of foods in comparison to each other and to non-food items), and iii) Hedonic response (the subjective pleasure experienced in consumption) to food intake


Locations(1)

University of Cambridge

Cambridge, United Kingdom

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NCT06112964


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