RecruitingPHASE2INTERVENTIONAL

Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease

This study is for adults with lung cancer, or a small number of lung tumours, who also have a lung condition called Interstitial Lung Disease (ILD). These patients are having radiotherapy to treat their cancer. We want to see if two different medicines, N-Acetylcysteine (NAC) and a short course of steroid tablets, can help reduce breathing difficulties that can sometimes happen after radiotherapy. People will be split into four groups and given either NAC or a dummy pill (placebo), and also either steroids or a dummy pill. This is a "double-blind" study, meaning neither you nor your doctors will know which treatment you are getting, to make sure the results are fair. We hope this study will help us find better ways to protect the lungs during cancer treatment.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

David Palma

Enrolment target

Start

07 Jan 2025

Estimated completion

31 Dec 2032

Lung Cancer Interstitial Lung Disease

What is this study about?

When people have radiotherapy for lung cancer, it can sometimes cause irritation and swelling in the lungs, which can lead to breathing problems. This is a common side effect. Patients who also have a condition called Interstitial Lung Disease (ILD) might have a higher chance of developing these breathing problems after radiotherapy. ILD makes the lung tissue scarred and stiff, which can already make breathing harder.

This study aims to find out if certain medicines can protect the lungs and reduce these breathing difficulties. We are testing two treatments: N-Acetylcysteine (NAC) and a short course of steroid tablets. NAC is an antioxidant, which means it might help protect cells from damage. Steroids are known to reduce swelling. By giving these medicines alongside radiotherapy, we hope to make treatment safer and more comfortable for patients with ILD.

Participants will be placed into one of four groups by chance, like flipping a coin. Some will get NAC, some will get a dummy pill that looks like NAC. Similarly, some will get steroid tablets, and some will get a dummy pill that looks like the steroids. Neither you nor your research team will know which treatment you are receiving, which helps us get unbiased results. This study is important because it could lead to better ways to support people with ILD who need radiotherapy for lung cancer.

Key takeaways

This study investigates ways to protect lungs during radiotherapy for lung cancer in people with ILD.
It tests two medicines: N-Acetylcysteine (NAC) and a short course of steroids.
Participants will be randomly assigned to receive active treatments or dummy pills (placebos).
The main goal is to reduce breathing problems that can occur after radiotherapy.
This research aims to improve comfort and safety for patients with both conditions.

Who may be eligible?

This study is for adults, aged 18 or over, who have lung cancer or a small number of tumours in their lungs. You must be planning to have strong radiotherapy for your cancer. You also need to have Interstitial Lung Disease (ILD), which has been confirmed by a lung specialist. It's helpful if your cancer diagnosis has been confirmed by a biopsy, but it's not always strictly required if a biopsy isn't safe for you.

There are also some important health checks to make sure you can safely take part. You should generally be well enough to carry out most daily activities, though some limitations are okay. You must be expected to live for more than six months. If you are a woman of childbearing age, you must use effective contraception during the study. If you've had radiotherapy to your lungs before, or if you're currently taking steroid tablets or infusions, you wouldn't be able to join this study.

Some medicines need to be stopped before and after radiotherapy if they could affect the study results, but some common anti-fibrotic treatments for ILD are usually allowed. Your doctor will be able to tell you more about whether this study is suitable for you based on all your health conditions and medications.

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?
Do you have lung cancer or a small number of lung tumours being treated with radiotherapy?
Has a lung specialist confirmed you have Interstitial Lung Disease (ILD)?
Are you generally well enough to do most daily activities?
Have you NOT had previous radiotherapy to your lungs?
Are you NOT currently taking oral or IV steroid medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly assigned to one of four groups. You will receive either N-Acetylcysteine (NAC) or a placebo (a dummy pill), and also either a short course of steroids or a placebo. You'll take these pills around the time of your radiotherapy. Neither you nor your doctor will know which treatment you are getting. You will have regular appointments and tests, including CT scans, to monitor your lung health and any side effects. The main thing we'll be looking at is how your breathing is after radiotherapy. The total duration of your participation, including follow-up appointments, will be explained to you by the study team, but it will involve attending several visits over a period.

Potential risks and benefits

Participating in this study might offer a potential benefit if the treatments being tested help reduce breathing problems after radiotherapy. However, there's no guarantee you will receive the active medicines or that they will work for you. There could also be side effects from either NAC or the short course of steroids, although the doses and duration are designed to be as safe as possible. Your study team will discuss all known and potential side effects with you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

BC-Cancer Agency - Vancouver
Verified postcode
Vancouver, Canada· Recruiting
Verspeeten Family Cancer Centre, London Health Sciences Centre
Verified postcode
London, Canada· Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is Interstitial Lung Disease (ILD)?

ILD is a group of conditions that cause scarring and stiffness in your lungs, making it harder to breathe.

What is radiotherapy?

Radiotherapy is a cancer treatment that uses high-energy rays to kill cancer cells and shrink tumours.

What does 'double-blind' mean?

It means neither you nor your doctors will know if you are getting the active medicine or a dummy pill, which helps make the study results very fair.

Will I still get my usual cancer treatment?

Yes, you will still receive your planned radiotherapy for lung cancer. The study medicines are given in addition to this.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point without it affecting your medical care.

How to find out more

David Palma, MD

david.palma@lhsc.on.ca 519-685-8650 Official trial record

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