Neurobehavioural and Cognitive Changes in Cancer Cachexia (CANCOG)

NCT06112964 | Recruiting

• 1 other identifier: A096708
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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. 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. 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?

Conditions

Cancer; Cachexia; Cachexia-Anorexia Syndrome; Appetite Loss; Weight Loss

Outcome Measures

Primary Outcomes (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.

  Eligible participants will undergo an MRI scan during a 1-hour scanning session at Wolfson Brain Imaging Centre.

  1 hour

Secondary Outcomes (4)

• To determine if there is a difference in food motivation and reward -based behaviour using functional MRI.

  1 hour

• Participants will be asked to perform two computer based tasks after the MRI scan, which have been validated to assess food reward and motivation.

  2 hours

• To compare responses to questionnaire-based measures of food attitudes, food intake and relevant psychopathology across patients with cancer related weight loss and healthy volunteers.

  1 hour

• To secure an archive of blood samples for potential future analysis as other targets may become available with research progression locally or within the wider CANCAN consortium

  5 minutes

Study Arms (2)

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.

Procedure: MRI/ Functional MRI; Behavioral: Self-reported questionnaires; Behavioral: Computer based tasks

Healthy volunteers

No malignancy or weight loss in the past 6 months

Procedure: MRI/ Functional MRI; Behavioral: Self-reported questionnaires; Behavioral: Computer based tasks

Interventions

MRI/ Functional MRI PROCEDURE

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.

Healthy volunteers; Participants with cancer and cancer associated weight loss/ loss of appetite

Self-reported questionnaires BEHAVIORAL

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.

Healthy volunteers; Participants with cancer and cancer associated weight loss/ loss of appetite

Computer based tasks BEHAVIORAL

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; Participants with cancer and cancer associated weight loss/ loss of appetite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A maximum of 50 participants will be recruited to this study over a period of 4 years. This will include approximately 30 participants with cancer, and 20 healthy volunteers. Participants with cancer will be recruited from oncology outpatient clinics or multi-disciplinary team meetings including palliative care MDT meetings at Addenbrooke's Hospital, Cambridge. Healthy volunteers will be recruited by advertising on site, study recruitment notice boards or through a contact of the participant with cancer. Participants in each group will be matched for age and sex

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cambridge: lead

Study Sites (1)

University of Cambridge

Cambridge, CB20QQ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

A 10-20ml blood sample will be collected from participants and stored for possible future batch analysis of analytes considered relevant to metabolism, nutrition, body composition, neuro-behaviour or appetite control,

MeSH Terms

Conditions

Neoplasms; Cachexia; Anorexia; Weight Loss

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Anthony P Coll

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony P Coll, MD PHD

CONTACT

01223 769041; apc36@cam.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Associate Professor

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 2, 2023
• Study Start: February 15, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)