A study looking at loss of appetite related to cancer treatment (ANCHOR)
Cancer type:
Status:
Phase:
This study is looking at the differences between people with who have lost their appetite and those who still have their appetite.
It is open to people with an advanced cancer of:
- the stomach
- where the food pipe joins the stomach (gastro oesophageal junction)
- the food pipe (oesophagus)
This study is only for people who are due to have treatment at The Christie Hospital in Manchester.
More about this trial
It is not known why people lose their appetite when they have advanced cancer. They can experience this loss of appetite in different ways including:
- not feeling hungry
- not liking food
- not enjoying eating
- feeling full very quickly
In this study, everyone will have the chemotherapy their doctor prescribed. The researchers want to look at the relationship between:
- your appetite
- how fit you are
- how well you tolerate chemotherapy
- how well chemotherapy works for you
- any care and advice you receive about your diet
The main aims of the study are to:
- find out more about how loss of appetite relates to how people tolerate chemotherapy
- find out more about how we can better understand and assess this
- look at the impact of dietary information you receive
Please note, you won’t benefit directly if you take part in this study. But it might help other people in the future.
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
There are 2 sub studies in this study. The study team might ask you to join one of the sub studies. Each sub study has certain entry conditions. Your doctor or a member of the study team will tell you about these entry conditions. The entry conditions below apply to everyone who might be able to take part. |
You may be able to join this study if all of the following apply. You have one of the following cancers:
- stomach (gastric) cancer that has spread to another part of the body (stage 4) or has grown into the surrounding tissue (locally advanced) and cannot be removed by surgery
- gastro oesophageal cancer that has spread to another part of the body (stage 4) or has grown into the surrounding tissue (locally advanced) and cannot be removed by surgery
- oesophageal cancer that has spread to another part of the body (stage 4) or has grown into the surrounding tissue (locally advanced) and cannot be removed by surgery
And the following apply. You:
- have not had any
chemotherapy or
immunotherapy for your cancer that has spread
- are due to have a
course of chemotherapy for
palliative treatment at The Christie Hospital
- are at least 18 years old
Who can’t take part
You cannot join this study if any of the following apply. You:
- are not having any cancer treatment that reaches the whole body, such as chemotherapy or immunotherapy, at The Christie Hospital
- are due to have surgery only
- have been referred to The Christie Hospital for a second opinion
Trial design
The team need up to 450 people to join the study.
Everyone fills in 3 questionnaires:
- before you start treatment
- about halfway through your treatment
- at the end of your treatment
The questions ask about:
- your diet and appetite
- your
quality of life - what information you have received about diet
You have some measurements taken to find out about how much you are eating and your muscle strength. This is a part of your standard care. Your doctor or a member of the study team will tell you more about these.
These tests include:
- height and weight
body mass index (BMI) - strength of your hand grip
- sit to stand test – where you are asked to stand as quickly and safely as you can from a sitting position
- finding out how well you can swallow
The team might also ask if you are willing to have some further tests. These include:
- an ultrasound of the leg
- a poo (stool) sample
- a test that looks at the nerves at the back of the eye
The ultrasound of the leg measures the size of the leg muscle. This gives the researchers information about your overall fitness.
The team use the poo sample to find out about the microbiome of your gut. The is the organisms that are naturally found in the gut. Everyone’s microbiome is unique to them.
The eye test gives the team information about the relationship between your nerves and muscles.
You don’t have to agree to have these tests done. You can still take part in the study.
The team will look at your medical notes to find out more about how your treatment affects your appetite.
Sub studies
The team will ask some people to take part in one of the . You will have an extra test done if you agree to take part. You have the test done on a different day to your standard care tests.
In the first sub study, you have a test called . The team use this to find out about the relationship between the following:
- your physical fitness
- the amount of muscle in your body
- your cancer symptoms
For this test, you are asked to exercise on an exercise bicycle whilst breathing through a mouthpiece. This is moderate exercise. You will not be asked to do more than you feel able to do. You exercise for about 10 minutes and the test as a whole takes about 40 minutes.
In the second sub study, you have blood tests taken before and after a meal. The team use these to find out about the levels in the gut that affect appetite and how chemotherapy changes these levels.
This involves a period of time overnight when you don’t eat. Then you have some soup, followed by blood tests at certain time intervals and then a further meal. You have some tests to look at your strength. Then you are asked to record your food intake at home for the next 24 hours. Your appointment will take about 4 hours in total.
A member of the study team or your doctor will tell you more about these sub studies and the tests involved.
You don’t have to agree to join either of these sub studies. You will still be part of the main study.
Hospital visits
There are no extra visits if you take part in the main study.
There is one extra visit if you agree to take part in one of the sub studies.
Side effects
The study team do not expect you to have any side effects from taking part in the study.
You may have some mild side effects from the extra tests in the sub studies. Having a CPET test may cause some symptoms due to the moderate exercise. The trial team will monitor you closely and will stop the testing if you feel unwell.
Having a blood test, as part of the second sub study, could cause some pain and bruising at the injection site. Some people may feel a bit sick when they don’t eat for a period of time or following the meal. The study team can give you an anti sickness tablet if you need it.
We have information about the side effects of chemotherapy.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Was Mansoor
Supported by
Manchester Metropolitan University
The Christie NHS Foundation Trust
University of Manchester
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040