A study looking at weight loss in people with cancer (MIPPaC)
Cancer type:
Status:
Phase:
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 
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 .
Cachexia can make you feel very tired and weak (fatigue) and affect your quality of life. It can also affect your . 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 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.
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).
- 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
- 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.
. 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 . 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.
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
Dr Claire Connell
Supported by
Cambridge University Hospitals NHS Foundation Trust
Cancer Research UK Cambridge Institute
Pancreatic Cancer UK
University of Cambridge
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
