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. The team also need 20 healthy volunteers to take part.

There are 2 groups:

up to 15 people in group A
the rest in group B

People with cancer and people in group A
At the start of the study you fill in a food diary at home. You do this for 2 to 5 days. You record what you eat in the diary.

You then 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.

Before going into hospital you take 4 spit (saliva) samples each day. The team will tell you when and how to collect these samples.

When you are in hospital you give a urine 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.

People in group B
You have 2 appointments at the hospital where you agreed to join the study. This is over 2 days. The first appointment is in the afternoon of day 1. The other is in the morning of day 2.

You give a urine sample on the evening of day 1 and the morning of day 2. The team will explain what to do and give you bottles or pots to collect it in. You keep the samples in the fridge when you collect them and take them into the hospital when you go.

You give blood samples on both days. Some of these blood samples are 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.

Other samples for research
The team will ask for other samples including:

spit (saliva) sample
24 hour urine collection
poo (stool) sample

Your doctor will tell when and how often they take these samples.

These samples are optional you don't have to agree to do them. You can still take part in the study.

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

Doubly labelled water sub study
This sub study is only for people with cancer.

The team want to find out more about how much energy your body uses. They are asking some people with cancer to take part in a sub study. If you decide to take part in this part of the trial, you will drink about 100mls of doubly labelled water on Day 2.

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.

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.

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

Tests
People with cancer see the doctor for a physical examination and to see how they are. This happens before you agree to take part.

People with cancer and the healthy volunteers in group A have:

their height, waist, hip and thigh measured
a bone density (DXA) scan

The people with cancer are weighed twice after leaving hospital. Once between 13 and 26 days after their time in hospital. And once between 27 and 40 days after their time in hospital. You might be able to go to your local hospital or your GP to have your weight done. A member of the team will talk to you about this.

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.