Neurobehavioural and Cognitive Changes in Cancer Cachexia (CANCOG)
NCT ID: NCT06112964
Last Updated: 2024-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-02-15
2027-11-30
Brief Summary
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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
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Detailed Description
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Previous research into conditions such as obesity and anorexia have shown the importance of signals between the body and the brain in controlling appetite. This study will focus on how cancer affects signals within the body which are communicated to the brain. In people with cancer, these signals may be altered, leading to changes in appetite and less pleasure from eating, ultimately resulting in weight loss (cancer cachexia).
The study will be observational and will be carried out in one centre at the Translational Research Facility, Addenbrookes Hospital. Researchers aim to recruit 50 participants (30 with cancer and weight loss, and 20 healthy volunteers).
Potential participants will be identified by clinical teams in oncology clinics, via recruitment posters and multi-disciplinary team meetings on the hospital site. Participants will attend for one study visit lasting 4 hours. During this time, participants will undergo an MRI scan, complete questionnaires and perform computer based tasks. Researchers will look for changes within the brain, and changes in body-to-brain signals in people with cancer and people who do not have cancer. Researchers will assess attitudes to eating and body perceptions using questionnaires and computer based tasks. This will indicate whether cancer is driving changes in behaviour which may cause weight loss (cachexia). The ultimate goal is to develop treatment strategies in future to prevent weight loss and improve outcomes for people with cancer
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Participants with cancer and cancer associated weight loss/ loss of appetite
Participants with confirmed malignancy, reporting weight loss of \>5% body weight in 6 months, or loss of appetite.
MRI/ 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.
Self-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.
Computer 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
Healthy volunteers
No malignancy or weight loss in the past 6 months
MRI/ 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.
Self-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.
Computer 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
Interventions
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MRI/ 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.
Self-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.
Computer 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
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University of Cambridge
OTHER
Responsible Party
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Dr Anthony Coll
University Associate Professor
Principal Investigators
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Anthony P Coll
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge
Locations
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University of Cambridge
Cambridge, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Tony Coll
Role: primary
Other Identifiers
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A096708
Identifier Type: -
Identifier Source: org_study_id
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