RecruitingNAINTERVENTIONAL

Optimizing Patient Treatment With EPA-enriched Nutrition, a Randomised Control Trial

This study, called OPT-EPA, is for people with lung or bowel cancer who are finding it hard to eat enough and are losing weight. Malnutrition can make cancer treatment harder and affect how you feel day-to-day. The study aims to see if a special nutritional drink, Fortimel Forticare Sensations (FFS), can help. This drink is packed with protein, calories, and omega-3 fats (like those in oily fish), which are known for reducing inflammation. Participants will either receive this drink along with dietary advice, or just dietary advice with other supplements if needed. Researchers will check if FFS helps improve weight, muscle strength, and overall well-being for people with cancer.

At a glance

Status

Recruiting

Phase

Sponsor

University of Edinburgh

Enrolment target

118

Start

01 Apr 2026

Estimated completion

01 Jun 2027

Malnutrition (Calorie)Colorectal Cancer Lung Cancer

What is this study about?

When you have cancer, it's common to struggle with eating and keeping your weight up. This can lead to what doctors call malnutrition, which means your body isn't getting enough important nutrients. Malnutrition can make you feel tired and weak, and it can also make cancer treatments less effective. It can be a really difficult part of living with cancer, affecting both your physical health and your emotional well-being.

Experts agree that good nutrition is a vital part of cancer care. Often, dietitians give advice, and sometimes special nutritional drinks are suggested. This study focuses on a specific drink called Fortimel Forticare Sensations (FFS). This drink is designed to give you lots of protein and calories in a small serving, which can be easier to manage, especially if your taste buds have changed. It also contains omega-3 fatty acids, similar to those found in oily fish. Omega-3s are thought to help reduce inflammation in the body, which can be a problem for people with cancer.

The OPT-EPA study wants to find out if taking this FFS drink, alongside standard dietary advice, makes a real difference for people with lung or bowel cancer who are at risk of malnutrition. Participants will be split into two groups: one will get the FFS drink and dietary advice, and the other will get dietary advice and other nutritional support if their doctor thinks they need it. The researchers will then compare how both groups fare in terms of their weight, muscle strength, inflammation levels, and how they generally feel, hoping to learn if these omega-3 enriched supplements can significantly improve health for people living with cancer.

Key takeaways

This study explores a nutritional drink for lung or bowel cancer patients struggling with malnutrition.
The drink, FFS, contains protein, calories, and anti-inflammatory omega-3 fats.
Participants will be divided into two groups to compare FFS with standard nutritional care.
Researchers will check if FFS improves weight, muscle, and overall quality of life.
The goal is to find better ways to support cancer patients' nutrition.

Who may be eligible?

This study is looking for adults aged 18 or over who have stage III or IV lung or bowel cancer that is not being treated to cure it. You should be planning to start your regular cancer treatment soon (within the next 4 weeks) or already be having it.

To join, you should be at risk of malnutrition. This means your body mass index (BMI) is less than 20, or you've lost between 5% and 10% of your body weight in the last six months. You also need to have some signs of inflammation in your body. Your doctor will check for this with a blood test.

There are some reasons why you might not be able to join. For example, if you've had surgery to remove a tumour in the last year, if you've lost more than 10% of your body weight in the last six months, or if you have severe kidney or liver problems. You also can't be taking other nutritional supplements or using any kind of artificial feeding when the study starts. Women who are pregnant or could become pregnant and are not using contraception cannot take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 or older?
Do you have stage III or IV lung or bowel cancer (not for cure)?
Are you starting or already having cancer treatment?
Have you lost between 5% and 10% of your weight in the last 6 months, or is your BMI below 20?
Are you able to attend appointments and follow study instructions?
Are you not currently pregnant or planning to become pregnant without using contraception?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be part of it for a set period, which the study team will explain. You will be asked to attend several appointments for assessments. These will include having your weight, height, and other body measurements taken. You may also have blood tests to check things like inflammation levels. You’ll be asked to fill out questionnaires about your diet, how you feel, and your quality of life.

If you are in the group receiving the special nutritional drink (FFS), you will be asked to drink it regularly as instructed. If you are in the other group, you will receive dietary advice and other supplements will be provided only if your doctor decides they are necessary for your health. The study team will monitor your health throughout the study. The total duration of your involvement, including all follow-up appointments, will be clearly explained to you before you agree to take part.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer monitoring of your nutrition and health than you would usually receive, and if you are in the group receiving the FFS drink, it might help improve your weight, strength, and how you feel. However, there's no guarantee that you will personally benefit from taking part. Potential risks might include minor side effects from the nutritional drink, like an upset stomach, though these are usually mild. There's also the inconvenience of extra appointments and tests. You can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Oslo University Hospital
Verified postcode
Oslo, Norway· Not yet recruiting
Edinburgh Cancer Centre
Verified postcode
Edinburgh, United Kingdom· Recruiting
Gateshead NHS Trust
Verified postcode
Gateshead, United Kingdom· Recruiting
Clatterbridge Cancer Centre
Verified postcode
Liverpool, United Kingdom· Recruiting

Common questions

What is malnutrition and why is it important in cancer?

Malnutrition means your body isn't getting enough important nutrients, often leading to weight loss and weakness. For cancer patients, it can make treatments harder and reduce overall well-being.

What is Fortimel Forticare Sensations (FFS)?

It's a special nutritional drink packed with protein, calories, and omega-3 fats, designed to help people with cancer get the nutrients they need.

What are omega-3 fatty acids?

These are healthy fats, like those found in oily fish, known for potentially reducing inflammation in the body.

Will I definitely get the special drink?

No, you will be randomly placed into one of two groups. One group gets the FFS drink, the other gets dietary advice and standard nutritional support if needed.

What does 'non-curative intent' mean for my cancer treatment?

It means your cancer treatment aims to control the disease and manage your symptoms, rather than trying to cure it completely.

How to find out more

Jessica Kelly

opt-epa@soton.ac.uk +442380599247 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.