NCT06112964 Neurobehavioural and Cognitive Changes in Cancer Cachexia (CANCOG)
| NCT ID | NCT06112964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cambridge |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-02-15 |
| Primary Completion | 2027-11 |
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 50 participants in total. It began in 2024-02-15 with a primary completion date of 2027-11.
⚠ 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
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 Criteria
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 exclusion criteria for healthy volunteers: * Have, or be recovering from, any form of cancer * Unintentional weight loss of \>5% body weight or unexplained loss of appetite
Contact & Investigator
Anthony P Coll
PRINCIPAL INVESTIGATOR
University of Cambridge
Frequently Asked Questions
Who can join the NCT06112964 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06112964 currently recruiting?
Yes, NCT06112964 is actively recruiting participants. Contact the research team at apc36@cam.ac.uk for enrollment information.
Where is the NCT06112964 trial being conducted?
This trial is being conducted at Cambridge, United Kingdom.
Who is sponsoring the NCT06112964 clinical trial?
NCT06112964 is sponsored by University of Cambridge. The principal investigator is Anthony P Coll at University of Cambridge. The trial plans to enroll 50 participants.
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