An observational study in Cancer, Cachexia and Cachexia-Anorexia Syndrome, sponsored by University of Cambridge. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by University of Cambridge · Observational
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:
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
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
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →University of Cambridge is the lead sponsor of 116 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General inclusion criteria for all groups:
Additional inclusion criteria for participants with cancer:
Exclusion Criteria:
General exclusion criteria for all groups:
Additional exclusion criteria for participants with cancer:
Additional exclusion criteria for healthy volunteers:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No malignancy or weight loss in the past 6 months
Procedure: MRI/ Functional MRI · Behavioral: Self-reported questionnaires · Behavioral: Computer based tasks
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.
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.
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
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.
Time frame: 1 hour
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.
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.
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.
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.
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
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
A 10-20ml blood sample will be collected from all participants
Time frame: 5 minutes
Plan to share: No
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