A study looking at weight loss in people with cancer (MIPPaC)

Cancer type:

All cancer types

Status:

Open

Phase:

Other

This study is looking at why some people with cancer lose a lot of weight and what causes it.

It is open to people with a solid cancer Open a glossary item that is any cancer that is not a blood cancer (a haematological cancer). And who are able to attend the Cambridge University Hospitals NHS Foundation Trust.

The team are also looking for healthy volunteers to take part.

More about this trial

Some people with cancer can have severe weight loss. This is cachexia. This most commonly happens to people with an advanced cancer Open a glossary item .

Cachexia can make you feel very tired and weak (fatigue) and affect your quality of life. It can also affect your immune system Open a glossary item . This can affect how well any treatment that helps your immune system find and kill cancer cells works.

Why people with cancer lose weight isn’t understood very well. In this study researchers are looking at:

people with cancer who do or do not have weight loss
and healthy volunteers whose weight is stable

They will do tests that look at the immune system and how the body changes food into the chemicals it needs.

The aim of the study is to understand why and how weight loss happens in people with cancer. They hope this will help researchers to find ways or treatments to help reverse the weight loss and improve the outcomes for these people.

Please note you won’t receive any direct benefit from taking part in the study. The results from this study could help 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.

Who can take part

People with cancer
You may be able to join this study if all of the following apply. You:

have a solid cancer
are wiillng and able to fulfil all the study visits and procedures
are at least 18 years old

Healthy volunteers
You may be able to join this study if you are at least 18 years old.

Who can’t take part

People with cancer
You cannot join this study if any of these apply. You:

have a blood cancer such as leukaemia or lymphoma
are having chemotherapy within 7 days of starting the study
are taking steroids or other medication that affects how well your immune system works. This is either within 7 days of starting the study or if you need it during the study.
have an active infection
cannot tolerate dairy products
have any other medical condition or mental health problem that could affect you taking part
are pregnant or breastfeeding

Healthy volunteers
You cannot join this study if any of these apply. You:

have or had any type of cancer
have symptoms of an active infection
are taking medication such as steroids that affect how well the immune system works. This is either within 7 days of starting in the study or if needed during the study.
are taking anti inflammatory medication such as aspirin. This is either within 7 days of starting in the study or if needed during the study.
have an ongoing illness that is related to the immune system such as multiple sclerosis and psoriasis. This includes asthma if you need to take regular medication for it.
have any other medical condition or mental health problem that could affect you taking part
cannot tolerate dairy products
are pregnant or breastfeeding

Trial design

The team need 60 people with a solid cancer. This includes at least 20 people who are losing weight and at least 20 people who aren’t losing weight. You see the doctor before you agree to take part. This is for a physical examination Open a glossary item and to see how you are.

The team also need 30 healthy volunteers to take part.

There are 2 groups in the study, group A and group B. You can choose which group you want to be in.

People in group A have 2 days in hospital. This includes an overnight stay.

People in group B will go to the hospital on a single day.

Between 2 to 5 days before your hospital visit, the team will ask you to:

complete a food diary, writing down what you eat. Those in group B do not have to agree to do this.
take 5 spit (saliva) samples each day. Those in group B do not have to agree to do this.
do a 24 hour urine collection. You do not have to agree to do this whether you are in group A or group B.
take poo (stool) samples. You do not have to agree to do this whether you are in group A or group B.

If you agree to do the urine collection or poo sample, your doctor will tell when to take them and how. They will also give you the bottles and pots to collect them in. You keep the samples in the fridge and bring them with you when you go to the hospital.

The team use these samples to find out more about cachexia, why it happens and how.

People in group A

You have an overnight stay in hospital. On the 2 days you are in hospital you have standardised meals. These meals have exact amounts of carbohydrates, proteins and fat. This allows the team to assess how much your body digests and absorbs.

Before going into hospital the team will talk to you about any food allergies you might have and your food preferences. Where possible the team will tailor the meals for vegetarians and religious requirements.

On the first day you have a lunch and an early dinner. You then have nothing to eat overnight. You can drink water. This is a fast for the tests and samples on the morning of the next day.

After the tests you have a breakfast which is a milkshake style drink such as Ensure Plus.

When you are in hospital you give urine samples, a poo sample and several blood samples.

The team take some blood samples as a finger prick. You will also have a thin tube (cannula) put in a vein in your arm. The team will take the rest of the blood samples through this tube.

The team will also:

take your height
weigh you
measure your hips
measure your thighs
measure the volume of your body. They will explain how they do this.

You have a bone density scan (DXA scan).

People with cancer in group A

People with cancer are weighed twice after leaving hospital. This is:

once between 13 and 26 days after
once between 27 and 40 days after

You might be able to have this done at your local GP. A member of the team will talk to you about this.

People in group B
Before your hospital visit you must have nothing to eat overnight. You can drink water. This is a fast for the tests and samples on the morning of the next day.

During your visit, the team will collect blood samples. Some of these blood samples are a finger prick. You may also have a thin tube (cannula) put in a vein in your arm, the team will take the rest of the blood samples through this tube.

The following are optional during your hospital visit:

height, waist, hip, thigh and body volume measurements
a bone density (DXA) scan
3 hour urine collection
poo (stool) sample collection
standardised morning meal at 11am

People with cancer in group B

People with cancer are weighed twice after leaving hospital. This is:

once between 13 and 26 days after
once between 27 and 40 days after

You might be able to have this done at your local GP. A member of the team will talk to you about this.

You do not have to agree to do this.

Doubly labelled water sub study

The team want to find out more about how much energy your body uses. They are asking some people to take part in a sub study Open a glossary item

. You don’t have to take part in this sub study.

Ordinary water contains hydrogen and oxygen. Doubly labelled water contains more of these elements which makes it easier to find when passed in urine. It is completely harmless.

If you decide to take part in the sub study, you will drink about 100mls of doubly labelled water on Day 2 for Group A or at the end of your visit for Group B.

Once you have had the drink you need to collect urine samples at home for 10 days. You have pots in which to collect the sample and a diary to record when you collected it. You keep the urine samples in your fridge and return them when you go back for a follow up appointment.

The team use these samples to find out how much energy your body uses.

Side effects

You might have some discomfort, bruising and bleeding when you have the cannula put in for the blood samples.

The DXA scan uses radiation Open a glossary item . This is an extremely small amount that is about the same as 8 hours of natural background radiation. The chances of the radiation having any affect is very small.