Condition category
Cancer
Date applied
04/04/2019
Date assigned
10/04/2019
Last edited
12/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Craniopharyngioma, although a non-malignant brain tumour, causes major health problems because of its location. It is near vision nerves, the pituitary gland controlling many hormones, and brain centres controlling appetite. Treatment involves surgery and radiotherapy, which can cause further damage. Obesity and associated long-term risks are common, and the reasons are complex. Through this project, we will investigate obesity in young people with craniopharyngioma. We want to find out if obesity is related to overeating from a lack of feeling full, appetite hormones not functioning or low metabolic rate.

Who can participate?
Patients aged between 7-25 years who have a diagnosis of craniopharyngioma

What does the study involve?
First, we will assess whether patients and their families are prepared to take part in research. Second, we will investigate which tests are best to use. We will measure the brain's response to food cues using special MRI scans and appetite hormones levels in the blood, as well as metabolic rate and questionnaires on quality of life and typical eating. Patients will eat lunch, so we can assess food choice and portion size. These measures will be analysed in relation to each patient’s craniopharyngioma severity and treatment, number and type of hormone problems and level of obesity.

What are the possible benefits and risks of participating?
Although craniopharyngiomas are rare (1-2 new childhood patients/per year in the South-west), this project has the potential to identify novel interventions. It will make a real impact to improve quality of life and health in craniopharyngioma patients with unmet complex needs related to obesity. These projects could also help us understand how weight problems could develop after other brain injuries.

Where is the study run from?
University Hospitals Bristol Education & Research Centre, UK

When is the study starting and how long is it expected to run for?
January 2019 to March 2020

Who is funding the study?
UHBristol Research Capability Fund

Who is the main contact?
Dr. Elanor Hinton, elanor.hinton@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elanor Hinton

ORCID ID

http://orcid.org/0000-0003-2793-8552

Contact details

NIHR Bristol BRC Nutrition Theme
University Hospitals Bristol Education & Research Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
0117 342 1500
elanor.hinton@bristol.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

3

Study information

Scientific title

Evaluating eating behaviours, energy homeostasis and obesity in childhood craniopharyngioma: A feasibility study

Acronym

Study hypothesis

The primary research question is whether functional neuroimaging and measurement of appetite hormones are useful tools to investigate hypothalamic obesity and eating behaviour in patients with craniopharyngioma.

Ethics approval

Approved 16/11/2018, South West -Frenchay Research Ethics Committee (Health Research Authority, Whitefriars, Level 3 Block B, Lewins Mead, Bristol, BS1 2NT; nrescommittee.southwest-bristol@nhs.net; 0207 1048028), ref: 18/SW/0235, IRAS project ID:250104

Study design

Observational cross-sectional cohort single-centre feasibility study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format please use contact details to request a participant information sheet.

Condition

Craniopharyngioma

Intervention

No intervention in this study.
It is a feasibility study measuring eating behaviour, appetite, functional magnetic resonance imaging (cerebral blood flow, response to food cues and resting brain networks), metabolic rate, OGTT in addition to measuring gastrointestinal hormones.

This study aims to investigate the feasibility of postulated methods of measuring appetite hormones, metabolic rate, neural response to food cues, and to characterise potential disruption between the hypothalamus and cortical limbic system in patients with craniopharyngioma. The insights gained from this feasibility study will inform a future multicentre trial to investigate the safety, efficacy and cost of a novel intervention in patients with craniopharyngioma to address their eating behaviour and obesity.

Objectives
1. Characterise the severity of the tumour, treatment and pituitary dysfunction in the studied craniopharyngioma patient population.
2. Assess whether sufficient patient numbers can be recruited.
3. Assess patient tolerability of the number and nature of measures used in the study.
4. Investigate which measures are the most informative to elucidate the nature of eating behaviour in those with craniopharyngioma-related obesity.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Characterisation of the severity of the tumour, treatment and pituitary dysfunction in the studied craniopharyngioma patient population. Assessed using a proforma and medical notes once patient recruited into the study.
2. Feasibility outcome (i) can sufficient patient numbers can be recruited (number recruited compared to number on clinic database).
3. Feasibility outcome (ii) patient tolerability of the number and nature of measures used in the study. Measure by an acceptability questionnaire at the end of the study session.
4. Preliminary data on the following: (i) functional MRI (using arterial spin labelling and BOLD fMRI scans), (ii) indirect calorimetry to measure resting metabolic rate, (iii) ad libitum food consumption (food choice and portion size), (iv) oral glucose tolerance test, measuring glucose, insulin, PYY, ghrelin, GLP-1 (5 time-points before and 30, 60, 90 and 120 post-glucose). (iv) Leptin will also be measured at baseline as well as a full blood count (FBC) and electrolytes (U&Es). (v) Appetite ratings are also given at the same timepoints during the OGTT.

Secondary outcome measures

1. Quality of life questionnaire (age appropriate) measured once using the MMQL.
2. Hyperphagic eating behaviour questionnaire
3. Adult or Child eating behaviour questionnaire
4. Body composition measured using multifrequency bioelectrical impedance, Tanita MC-780), to give fat-free mass and fat mass, and total body water

Overall trial start date

25/01/2018

Overall trial end date

31/03/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients aged between 7-25 years who have a diagnosis of craniopharyngioma

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Clinically unwell requiring hospital or intensive treatment
2. Unwilling to fast
3. Patients for whom it would be unsafe to have an MRI including those with:
3.1 Certain metal implants
3.2 Tattoos with metallic ink
3.3 Metal body piercings which cannot be removed
4. Pregnancy to avoid harm to the foetus
5. Claustrophobia in the closed MRI environment or unable to tolerate the MRI scanner
6. Weight above 152kg and/or girth greater than 210cm due to size limitations of MRI scanner

Recruitment start date

25/01/2019

Recruitment end date

31/03/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Research and Imaging Centre (CRICBristol)
60 St Michael's Hill
Bristol
BS2 8DX
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Research Governance Team
Research & Enterprise Development
University of Bristol
Trinity Street
College Green
One Cathedral Square
Bristol
BS1 5DD
United Kingdom
+44 (0)117 4284021
Rachel.Davies@bristol.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

UHBristol Research Capability Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish two papers from this study:
(1) a paper to report on the feasibility outcomes of this study, with the primary aim of reporting whether the measures chosen suitable to increase understanding of obesity and eating behaviour in craniopharyngioma.
(2) a paper to report the preliminary fMRI data for the response to food cues in three groups: patients with (i) craniopharyngioma, (ii) patients with obesity, and (iii)healthy weight control group ((ii) and (iii) are historical control data as ye unpublished from a previous study).
(NB we do not intend to publish the protocol for this study as it is not a full trial).

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository

The final, anonymised data-set (all measures) will be made available through Pure, the University Research Information System and institutional repository for the University of Bristol. The dataset will become available once the data has been fully analysed by the research team, so hopefully within one year of data collection completion. The research project may also be added to the Explore Bristol Research (EBR) - the public catalogue of the University's research. This is the weblink to the repository, which will be set up once the data is collected: http://www.bristol.ac.uk/red/research-policy/pure/about/

Intention to publish date

15/12/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/04/2019: Trial’s existence confirmed by IRB