A study looking at helping reduce loss of muscle mass in people with bowel cancer (FACILITATE)

Cancer type:

Bowel (colorectal) cancer

Secondary cancers

Status:

Open

Phase:

Other

This study is looking at exercise and diet to help reduce muscle loss in people with advanced bowel cancer.

It is open to people who have bowel cancer that:

has spread to another part of the body (advanced bowel cancer) or
can’t be removed by surgery

You must also be having treatment at the Belfast City Hospital, Northern Ireland.

More about this trial

People who have cancer can experience loss of muscle which can affect their quality of life Open a glossary item . It can also affect how bad the side effects of treatment might be. By reducing their muscle loss their overall quality of life can improve. And they may be able to cope better with the side effects of treatment. In some people, reducing the loss of muscle may also help the treatment work better.

We know from previous research that physical activity that helps increase or maintain muscle mass can help. And that an increase in the amount of protein in the diet can also help. But there is little information about how useful and practical this is for people during treatment for advanced bowel cancer.

In this pilot study Open a glossary item , you have a personalised exercise programme and advice on diet to help reduce muscle mass loss during your treatment. This is set out by a physical activity and nutrition coach who you will see once a week.

The aims of this study are to find out:

how acceptable the exercise programme and diet advice is for people with advanced bowel cancer who are having chemotherapy
whether this does reduce muscle loss during treatment
whether it is possible to do this study

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

You may be able to join this study if you are having treatment at the Belfast City Hospital, Northern Ireland and all of the following apply. You:

have an adenocarcinoma of the bowel or rectum that cannot be removed by surgery and is stage 3 or stage 4
have had a CT scan of the abdomen or pelvis within 3 months of joining the study
are to have chemotherapy that includes the drug fluorouracil (5FU) to relieve the symptoms of the cancer (palliative treatment). You can join before starting treatment or within the first 2 weeks of starting treatment.
are up for at least half the day, can look after yourself but might not be able to work (performance status 0, 1 or 2)
have satisfactory blood test results
are able, and willing, to do the muscle strength testing, physical testing and the muscle strengthening exercises (resistant based exercises). Your doctor will know about this.
are willing to eat what the coach sets out for you
are able and willing to talk with the coach
are at least 18 years old

Who can’t take part

Cancer related
You cannot join this study if any of these apply. You:

have had treatment such as chemotherapy that reaches your whole body within the past 3 months
are having chemotherapy to treat areas of cancer spread to the liver with the aim to cure. You might be able to join if you are having treatment to relieve the symptoms of cancer spread to the liver (palliative treatment). Your doctor will know this.
are having treatment for another cancer

Medical conditions
You cannot join this study if any of these apply. You:

had major surgery within the past 4 weeks or you have not recovered fully from major surgery
have severe nerve damage (peripheral neuropathy)
have high blood pressure that is not well controlled
have heart problems that could affect you taking part
have diabetes that is not well controlled
have had a stroke recently
have an infection that is not controlled
have a wound, ulcer or bone fracture that is not healing
have any other medical condition or mental health condition that could affect you taking part

Other
You cannot join the study if you are already doing muscle strengthening exercises for 2 or more days a week.

Trial design

This is a pilot study taking place at the Belfast City Hospital, Northern Ireland. The team need 20 people to take part.

You see a member of the research team who will explain the study to you. If you agree to take part, you will have a food diary to record what you eat for 3 days. This is before seeing the physical activity and nutrition coach. You bring this diary along with you to the first session.

You see a physical activity and nutrition coach at the outpatient gym in the Belfast City Hospital. They will:

explain what the sessions involve
discuss your diet and exercise goals
set out a plan to achieve these goals

You go to the outpatient gym at the treatment centre in Belfast City Hospital once a week for 12 weeks. Each week you have a one to one session with the coach.

At these sessions you have the opportunity to discuss your progress with the coach. You can also have the coach supervise your exercises at the session if you want them to.

The team will ask you to attend as many sessions as possible. Where possible they will schedule the sessions around your timetable and how you are feeling. The sessions will be about 45 minutes long.

You are encouraged to do these exercises at home in between these sessions.

You can have a family member or friend come with you to the exercise sessions.

At the end of the 12 weeks, your coach will discuss ongoing support to continue with your plan and goals.

Interview
The team might ask you, and your family member or friend, to take part in an interview. They will arrange a time and date that is convenient for you. It will take about an hour and be face to face or online.

The team will ask about:

your experience of taking part in the study
the sessions
what might be improved

The interview is recorded, and the interviewer will take notes. Everything you say and your details are confidential.

You don’t have to agree to do the interview. You can still take part in the study.

Samples for research
The team will ask for up to 4 blood samples. Where possible they will take these samples when you have blood tests taken as part of your routine care.

They will also ask for a piece of the cancer tissue (biopsy Open a glossary item ) that was taken previously.

They will use the tissue and blood samples to look for substances (biomarkers Open a glossary item ) that are made by the body in response to following the exercise and diet plan. The researchers want to find out whether these biomarkers affect how well chemotherapy works.

You don’t have to agree to these samples. You can still take part in the study.

CT scans
As part of your standard care, you will have a CT scan before and after chemotherapy to see how well treatment worked. The team will ask to have a look at these 2 scans. They want to assess your muscle mass before and after the exercise plan.

Hospital visits

You see the physical activity and nutrition coach at the outpatient gym in the Belfast City Hospital. On your first and last visit you:

have a physical examination
have tests to check your muscle strength
fill in questionnaires about your physical activities and quality of life
hand in your 3 day diet record
have your body composition checked. For this you need to fast from the night before. The team will tell more about this and give you a voucher for breakfast after the test is done.

You attend the outpatient gym at the Belfast City Hospital at least 1 day a week for 12 weeks.

Side effects

Your coach will show you how to do the exercises properly and safely. They will supervise you doing them to make sure you are doing them right.

You may experience sore muscles and joints when you start the exercises. This is especially if you are not used to doing muscle strengthening exercises. This can last for up to 2 days. Tell your coach if the sore muscles or joints are not getting better.

If you are not well, you may have an increased risk of falling when doing the exercises. Your coach will see how you are before the start of the exercise session.

Some exercise can put a strain on your heart if you have a heart problem. Tell your coach if you have any chest pain or feel unwell.

After having an operation to remove your bowel cancer you might have an opening from your bowel to the outside of your body on your tummy (abdomen). This is called a stoma. Some exercises can put pressure on the muscles of the abdomen. This can cause an internal part of the body to be pushed out of the stoma. This is called a hernia. Your coach will show you how to do these exercises safely to reduce the chances of this happening.

The risks of having a blood test include: