"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at a combination of treatments for weight and muscle loss in people with advanced cancer (MENAC)
More about this trial
Some people with cancer lose their appetite, lose weight and have extreme tiredness (fatigue). Your specialists might call this cachexia. At the moment, we don’t know what kind of treatments work best for this.
Doctors are interested in different ways of treating cachexia. In this trial researchers are looking into combining a number of treatments together. These are:
- exercise and diet advice
- a nutritional supplement – to provide you with extra calories
- a non steroidal anti inflammatory drug
The aim of the study is to see if the combination of these treatments helps people with weight loss, lack of appetite and fatigue. The researchers aim to start these treatments at an early stage, along with anti cancer treatment such as chemotherapy. This is to try and prevent or treat cachexia as soon as possible.
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial 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 trial if all of the following apply. You:
- have a type of lung cancer called non small cell lung cancer that is stage 3 or 4 or you have stage 3 or 4 pancreatic cancer
- are about to start first line or second line cancer treatment, this includes chemotherapy, immunotherapy, chemoradiotherapy, or drugs targeting specific gene changes in cancer cells (targeted cancer drugs)
- have had or will have a CT scan or PET-CT scan within 4 weeks of starting your cancer treatment - this is to see how big the cancer is and whether it has spread
- are able to have an assessment of how active you are, your weight and how you feel before the trial (baseline) within a week before starting treatment
- have satisfactory kidney function blood test results
- are able to care for yourself but not able to carry on with all your normal activities or do active work (Karnofsky performance score of more than 70)
- are willing to use reliable contraception during the study if there is a chance that you or your partner could become pregnant
- are at least 18 years old
Your doctor must also think you are fit enough to take part in the trial for the 12 weeks of the study.
Who can’t take part
You cannot join this trial if any of these apply. You:
- have a type of pancreatic cancer called a neuroendocrine pancreatic cancer
- are unable to take anti inflammatory medicine - your doctor can explain if this is not a suitable treatment for you
- have liquid food given by a drip into your vein (parenteral nutrition) or food through a feeding tube
- are having cancer treatment before surgery or radiotherapy to try and shrink the cancer and make this treatment more successful (neo adjuvant treatment)
- have a body mass index (BMI) of 30 or more – your doctor or nurse can work this out by measuring your height and weight
- have had drugs to help increase your appetite or help with muscle loss in the 30 days before the trial, these drugs include megestrol acetate – your doctor can advise you on this
- are having high dose steroid treatment which started less than 3 months ago. If you have had steroids by an inhaler, steroid eye drops or some doses of oral steroids for less than 10 days you might be able to take part
- have been taking any non steroidal anti inflammatory medicine or aspirin for longer than 7 days and it’s not safe to stop them
- are taking any medicines to thin your blood, for example warfarin or heparin and it’s not safe to stop them
- are pregnant or breastfeeding
This is a phase 3 study. Everyone taking part is put into one of 2 groups at random. Neither you nor your doctor will be able to decide which group you are in.
If you are in group 1, you have the trial treatments over 6 weeks. This includes:
- getting advice about the best way to make sure you eat enough food
- drinking a special supplement which is high and calories and nutrients, you have one drink twice a day
- following an exercise regime that has been designed for your needs (you do not need to be in good physical shape to take part in this study)
- taking the non steroidal anti inflammatory medicine
During your study visits, the team will ask you questions about:
- your quality of life
- what you eat
- how active you are
- your symptoms
You wear an electronic device on your leg for 7 days, at the start of the trial and at the end of the trial. It’s small and attaches to your leg with a plaster. This gives the researchers information about how active you are.
Doctors will also use information from everyone’s routine CT scans to help them in the study.
If you are in group 2, you won’t have this extra support straight away. This is so that the study team can see if the extra support people have in group 1 makes a difference. After 6 weeks, when the team have compared information, you will also have the treatment for the next 6 weeks.
You have blood tests twice during the study, so that researchers can learn more about cancer and cachexia.
The team will ask if they can store your samples for future research. The team hope these will help to find out why some people with cancer lose weight and improve treatment for cachexia. You don’t have to agree to this if you don’t want to, you can still take part in the trial. And your treatment won’t be affected.
After the trial
After you finish the trial, you might be able to carry on having the supplement drink along with advice about diet and exercise if you and your doctor think it has helped. The trial team can contact your GP about providing this.
Before you start the trial, you will have a physical examination. The team measures how well you are able to stand and walk a short distance. You also:
- have your weight measured
- a blood test
- give information to the trial team about how active you are, what you are eating and how you are feeling
These are called your baseline results. When you see the trial team after 6 weeks, they repeat most of the tests and questions. And then compare them to your baseline results.
You visit the hospital between 3 and 5 times as part of the trial. You will see a trial doctor or nurse. Where possible, this is on the same day as your normal hospital appointments. Each visit will last around 2 hours.
The trial team will provide transport or pay for your travel costs.
You have a CT scan before the start of the trial unless you have had one in the last 4 weeks. You then have another one after 6 weeks of starting the trial. You usually have these scans as part of your routine cancer care.
Side effects of non steroidal anti inflammatory medicine might include:
- stomach pain
- swelling or puffiness of your arms, legs or face (fluid retention)
There are less common, more serious side effects, such as a stomach ulcer. The trial team will assess you to see if you are at high risk of this. You won’t be able to take part in the study if you are at high risk.
You might find that exercise makes you feel tired or make your muscles uncomfortable at first. The exercises will be tailored to you, to try and prevent this.
You might have some loose bowel movements for the first few days of taking the supplement drink. You can build up to 2 drinks a day to give your body time to adapt.
How to join a clinical trial
Dr Barry Laird
Professor Marie Fallon
Marie Curie Cancer Care
The Rising Tide Foundation
Southampton Clinical Trials Unit
Norwegian University of Science and Technology