AuthorisedTherapeutic use (Phase IV)Interventional

Route of nutrition and muscle wasting after oesophagectomy – a randomised, controlled, observer blind trial

This research is investigating the best way to feed patients after they have surgery called an oesophagectomy. This operation is done to remove cancer from the food pipe (oesophagus). After this major surgery, people can lose a lot of muscle. The study is comparing different ways of giving nutrients, including a special liquid food called SmofKabiven, which is given through a drip. Researchers are trying to find out if one method is better at helping patients keep their muscle and recover well. This is a "Phase IV" study, meaning the treatment is already approved for use, and researchers are gathering more information about its effects.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Aarhus Universitet

Enrolment target

Start

16 Jan 2024

Oesophagectomy

What is this study about?

When someone has an oesophagectomy, which is an operation to remove part of the food pipe because of cancer, it's a big surgery. After such a major procedure, it's common for patients to lose muscle and feel weaker. This can make recovery harder and take longer.

This study, called "Route of nutrition and muscle wasting after oesophagectomy," is designed to find the best way to give patients food and nutrients after their operation. The main goal is to see if giving a specific type of liquid food, called SmofKabiven, through a drip into a vein helps patients keep their muscle mass better than other feeding methods. Researchers will measure muscle size using special scans before and shortly after the surgery.

The findings from this study are important because they could help doctors understand how to support patients' recovery more effectively after oesophageal cancer surgery. If a certain feeding method is shown to be better at maintaining muscle, it could lead to improved care, helping patients regain their strength and quality of life more quickly.

Key takeaways

This study focuses on improving recovery after oesophageal cancer surgery.
It compares different ways of giving food and nutrients after the operation.
The main aim is to see if certain feeding methods help maintain muscle strength.
Your muscle size will be measured before and after surgery using CT scans.
The study explores how to help patients recover better and reduce muscle loss.
Your participation could help improve care for future patients.

Who may be eligible?

This study is looking for adults aged 18 years and older. There is no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part in this research.

To be eligible, you would need to be scheduled for an oesophagectomy – this is surgery to remove part of your food pipe because of cancer. The medical team will check other details from your health records to make sure you can safely participate in the study.

It's important to remember that not everyone who has oesophageal cancer surgery will be able to join the study. Your doctors will discuss with you whether this study is a good fit based on your overall health and treatment plan.

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 years old or older?
Are you scheduled to have surgery for oesophageal cancer?
Are you happy for your treatment to be decided randomly for this study?
Are you able to attend follow-up assessments after your surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have some measurements taken before your surgery, likely including a special scan called a CT scan to measure your muscle size. After your oesophagectomy, you'll receive food and nutrients in one of the ways being tested in the study. This might involve a special liquid food given through a drip (an IV line). Another CT scan will be performed about 10 days after your surgery to see how your muscle size has changed. The doctors and nurses looking after you will monitor your recovery closely throughout your hospital stay. The specific type of feeding you receive will be decided by chance, like flipping a coin, to ensure a fair comparison. The total duration of active participation, including the measurements and special feeding, would be from before your surgery until about 10 days after.

Potential risks and benefits

Taking part in this study may offer the potential benefit of contributing to our understanding of the best ways to support patients after oesophageal cancer surgery, which could help future patients. For you personally, there's a chance that the specific feeding method you receive could be more beneficial for your muscle strength, but this is not guaranteed. As with any medical treatment or research, there are potential risks, such as side effects from the feeding methods or discomfort from assessments like CT scans, though these are standard procedures. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is an oesophagectomy?

It's an operation to remove part of the food pipe (oesophagus) usually because of cancer.

What is SmofKabiven?

It's a special liquid food given through a drip (IV) to provide nutrients when you can't eat normally.

Will I get this special food?

You might. The study will randomly assign participants to receive different types of feeding, including SmofKabiven, to compare them.

Why is muscle important after surgery?

Keeping muscle helps you recover faster, regain strength, and feel better after a major operation.

How long does the study last for me?

Your active involvement, including specific measurements and feeding, would be from before surgery until about 10 days afterwards.