Neurobehavioural and Cognitive Changes in Cancer Cachexia (CANCOG) (NCT06112964) | Clinical Trial Compass
RecruitingNot Applicable
Neurobehavioural and Cognitive Changes in Cancer Cachexia (CANCOG)
United Kingdom50 participantsStarted 2024-02-15
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
General inclusion criteria for all groups:
* Written informed consent
* Aged 18 years or over
* Willing and able to comply with study procedures and visits
Additional inclusion criteria for participants with cancer:
* 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:
General exclusion criteria for all groups:
* 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
Additional exclusion criteria for participants with cancer:
• Intracranial cancer or metastatic intracranial involvement of cancer
Additional excl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To characterise structural and functional neuroanatomy as well as neurometabolism through MRI brain imaging in participants with cancer related weight loss and healthy volunteers.