RecruitingNAINTERVENTIONAL

The PRIMROSE Trial

The PRIMROSE trial is for people with lung cancer who are planning to have surgery. Surgery can offer a cure, but lung damage from smoking can make it harder for some people to be fit enough. This study explores if using a small, hand-held breathing device, called an inspiratory muscle trainer, in addition to regular exercise (prehabilitation), can improve fitness even more. Researchers hope this extra training will help strengthen breathing muscles, lower the risk of problems after surgery, and reduce how long someone needs to stay in hospital. The study compares people who use the device with those who only do the standard exercises, then follows everyone for a year to see the results.

At a glance

Status

Recruiting

Phase

Sponsor

Swansea Bay University Health Board

Enrolment target

100

Start

01 May 2025

Estimated completion

01 May 2027

Cancer Lung Resection Inspiratory Muscle Training Prehabilitation Respiratory Complications Length of Hospital Stay

What is this study about?

If you have lung cancer, surgery can be a very effective treatment. However, smoking, which is a big cause of lung cancer, can also damage your lungs and make it harder to breathe. This can mean you're not as fit as you need to be for a big operation like lung surgery. If you're not fit enough, your doctors might recommend other treatments like radiotherapy or chemotherapy instead, even though surgery might be the best option for a complete cure.

To help people get ready for surgery, there's a programme called 'prehabilitation' (often shortened to 'prehab'). This is like a fitness programme to get you in the best possible shape before your operation. It aims to improve your fitness, reduce breathlessness, and make you less likely to have problems after surgery. This study is looking at whether adding a special breathing exercise device to this prehab programme can help even more. This small, hand-held device helps you train and strengthen the muscles you use for breathing.

The researchers think that by making your breathing muscles stronger, you might be even fitter for surgery. This could mean you have fewer problems after the operation and might even go home from the hospital sooner. The study will compare two groups of people having lung surgery: one group will do the standard prehab exercises plus use the breathing device, and the other group will only do the standard prehab exercises. By comparing these two groups, researchers hope to see if the breathing device makes a real difference to recovery.

Key takeaways

This study compares standard pre-surgery exercises with adding a breathing device.
It aims to make people with lung cancer fitter for surgery.
The goal is fewer complications and shorter hospital stays.
Participants will be followed for 12 months after surgery.
It's for adults (18+) with surgically treatable lung cancer.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with lung cancer, or are suspected of having it, and whose doctors think surgery could remove the cancer. You would also need to be already referred for the pre-surgery exercise programme (prehab) because of things like being a bit breathless, not being as active as usual, being over 70, or having some signs of frailty.

There are also some reasons why you might not be able to join. For example, if you have other types of cancer, or if your doctors think that doing the breathing exercises or general prehab might not be safe for you. This includes if you have certain heart conditions, a hernia, or certain lung conditions like a collapsed lung in the past. You also need to be able to understand and agree to take part in the study.

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 an adult aged 18 or over?
Do you have lung cancer that your doctors think can be removed with surgery?
Are you already referred for pre-surgery exercises (prehabilitation)?
Have your doctors told you that using a breathing device would be safe for you?
Can you understand and agree to take part in a research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might be asked to use a special breathing device at home, in addition to attending your regular prehabilitation sessions. The study will follow your progress for up to a year after your surgery. During this time, the research team will regularly check in with you to see how you are recovering and how you are feeling.

Potential risks and benefits

Taking part in this study could potentially help you become fitter for your surgery, possibly leading to a smoother recovery and a shorter hospital stay. However, there's no guarantee of benefit, and using the breathing device might feel a little unusual initially. All medical procedures carry some risks, but the breathing device itself is generally very safe. You have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Swansea Bay University Health Board
Verified postcode
Swansea, United Kingdom· Recruiting

Common questions

What is 'prehabilitation'?

Prehabilitation is like a fitness programme designed to get you in the best possible shape before your surgery. It helps improve your strength and breathing.

What is an inspiratory muscle training device?

It's a small, hand-held device that helps you exercise and strengthen the muscles you use when you breathe in. It's safe and easy to use.

How long will I be in the study?

You'll be followed up by the research team for about 12 months after your surgery to see how you're doing.

Will I definitely get the breathing device?

No, because it's a comparison study, you'll be put into one of two groups by chance: one group gets the device plus standard exercises, and the other only gets standard exercises.

Who is running this study?

This study is being run by researchers looking into better ways to prepare people for lung cancer surgery.

How to find out more

Ira Goldsmith, Professor

Ira.Goldsmith@wales.nhs.uk 44 01792 704084 Official trial record

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