CancerCANCOGNCT06112964
Neurobehavioural and Cognitive Changes in Cancer Cachexia (CANCOG)
An observational study of Cancer and Cachexia, run by University of Cambridge at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Cachexia, Cachexia-Anorexia Syndrome
- What is being tested?
- MRI/ Functional MRI, Self-reported questionnaires and Computer based tasks
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2024to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Cambridge
Cambridge, CB20QQ
Tony Coll
About this study
Official title: Understanding the Impact on CANcer on Neurobehavioral Mechanisms and COGnition in Cachexia (CANCOG)
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:
- 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
- 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?
Read more
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
Read the detailed description
Cancer cachexia is a complex disorder involving progressive loss of muscle and fat in people with cancer, which cannot be corrected with dietary supplements. It affects 50-80% of the cancer population, and accounts for up to 20% of cancer related deaths.To date there are no effective treatments for cancer cachexia and further research is needed to highlight possible treatments for this condition.
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
- Cancer, Cachexia, Cachexia-Anorexia Syndrome, Appetite Loss, Weight Loss
- Being tested
- MRI/ Functional MRI, Self-reported questionnaires, Computer based tasks
- Medical subject headings
- Neoplasms, Cachexia, Anorexia, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI/ Functional MRIProcedure or surgery
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 questionnairesBehavioural
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 tasksBehavioural
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:
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: MRI/ Functional MRI; Behavioral: Self-reported questionnaires; Behavioral: Computer based tasks | |
| Healthy volunteers | No malignancy or weight loss in the past 6 months Receives: Procedure: MRI/ Functional MRI; Behavioral: Self-reported questionnaires; Behavioral: Computer based tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (4)
To determine if there is a difference in food motivation and reward -based behaviour using functional MRI.
Participants will be asked to perform one computer based task during their MRI scan, which is called functional MRI. Imaging analysis of the results of this task will indicate differences in MRI responses in areas of the brain related to food reward and food motivation, between people with cancer and weight loss and healthy volunteers.
Measured: 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.
Participants will be asked to perform two computer based tasks using a laptop. The generated results of these tasks will indicate participants' level of food reward and food motivation and will allow for comparison between people with cancer and weight loss, and healthy volunteers.
Measured: 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.
The following questionnaires cover food attitudes and intake, and measures of psychopathology including depression and anxiety. These will be derived from standardised scales, used the setting of eating disorders and neuroscience of appetite studies. Questionnaire scores will be compared between people with cancer and weight loss and healthy volunteers.
Godin Leisure Time Exercise Questionnaire Functional Assessment of Chronic Illness Therapy- Fatigue Functional Assessment of Anorexia/Cachexia Therapy Activities of daily living questionnaire Instrumental activities of daily living scale Scored Patient Generated Subjective Global Assessment Edmonton Symptom Assessment Brief Pain Inventory Patient Health Questionnaire- 9 General Anxiety disorder Hospital Anxiety and Depression Scale Body Perception Questionnaire Snaith Hamilton Pleasure Scale The three factor eating questionnaire DSM-5 Self rated Level 1 Cross-cutting symptom measure
Measured: 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
A 10-20ml blood sample will be collected from all participants
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start15 Feb 2024
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anthony Coll, University of Cambridge
- Investigators
- Anthony P Coll, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112964
- Sponsor's protocol ID
- A096708
- Acronym
- CANCOG
- Status last verified
- Jul 2024
- First submitted
- 24 Oct 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Impact on CANcer on Neurobehavioral Mechanisms and COGnition in Cachexia (CANCOG)
- ClinicalTrials.gov ID
- NCT06112964
- Acronym / sponsor ID
- CANCOG / A096708
- Conditions
- Cancer, Cachexia, Cachexia-Anorexia Syndrome, Appetite Loss, Weight Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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
Detailed description
Cancer cachexia is a complex disorder involving progressive loss of muscle and fat in people with cancer, which cannot be corrected with dietary supplements. It affects 50-80% of the cancer population, and accounts for up to 20% of cancer related deaths.To date there are no effective treatments for cancer cachexia and further research is needed to highlight possible treatments for this condition.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with cancer and cancer associated weight loss/ loss of appetite | – | Procedure: MRI/ Functional MRI, Behavioral: Self-reported questionnaires, Behavioral: Computer based tasksParticipants with confirmed malignancy, reporting weight loss of >5% body weight in 6 months, or loss of appetite. |
| Healthy volunteers | – | Procedure: MRI/ Functional MRI, Behavioral: Self-reported questionnaires, Behavioral: Computer based tasksNo malignancy or weight loss in the past 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI/ Functional MRIParticipants 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. | Procedure or surgery | Healthy volunteers, Participants with cancer and cancer associated weight loss/ loss of appetite |
| Self-reported questionnairesParticipants 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. | Behavioural | Healthy volunteers, Participants with cancer and cancer associated weight loss/ loss of appetite |
| Computer based tasksParticipants 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 | Behavioural | Healthy volunteers, Participants with cancer and cancer associated weight loss/ loss of appetite |
Primary outcome
To characterise structural and functional neuroanatomy as well as neurometabolism through MRI brain imaging in participants with cancer related weight loss and healthy volunteers.
Time frame: 1 hour
Eligible participants will undergo an MRI scan during a 1-hour scanning session at Wolfson Brain Imaging Centre.
4 secondary outcomes
To determine if there is a difference in food motivation and reward -based behaviour using functional MRI.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony P Coll principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cachexia, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony P Coll, MD PHD (01223 769041 ext. +44, apc36@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterise structural and functional neuroanatomy as well as neurometabolism through MRI brain imaging in participants with cancer related weight loss and healthy volunteers. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.