Not yet recruitingPHASE2INTERVENTIONAL

Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation

This study is investigating a new way to prevent lung damage (called pneumonitis) in people with a specific type of lung cancer, non-small cell lung cancer (NSCLC), who are in Stage III. These patients are receiving standard treatments like chemotherapy and radiotherapy, often followed by immunotherapy. While these treatments are good at targeting cancer, radiotherapy can sometimes cause side effects in the lungs. This trial wants to see if adding two medicines, Pentoxifylline and vitamin E, can help protect the lungs, reduce side effects, and improve how patients feel overall. It compares these medicines to a dummy pill (placebo) to understand their real effect.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

University Health Network, Toronto

Enrolment target

150

Start

30 May 2026

Estimated completion

30 Nov 2032

Non-Small Cell Lung Cancer Radiation Induced Lung Injury (RILI)

What is this study about?

When someone has newly diagnosed, inoperable Stage III non-small cell lung cancer, doctors often use a combination of treatments. This usually includes chemotherapy and radiotherapy (high-energy rays to kill cancer cells), sometimes followed by newer immunotherapy drugs that help your body fight cancer. These treatments are chosen because they are very effective at treating the cancer. However, just like any strong medicine, they can sometimes cause side effects.

One common side effect, especially from radiotherapy to the chest, is called 'Radiation Induced Lung Injury' (RILI). This can lead to inflammation in the lungs (pneumonitis) or sometimes scarring (pulmonary fibrosis). These lung problems can make you feel unwell, affect your breathing, and impact your daily life. The risk of these problems can be even higher when you have several treatments combined, such as radiotherapy, chemotherapy, and immunotherapy.

This study is exploring whether a combination of two medicines, Pentoxifylline and vitamin E (alpha-tocopherol), can help prevent or lessen these lung problems. Previous research has suggested that Pentoxifylline, particularly when combined with vitamin E, might help protect the lungs from damage. This trial aims to see if adding these medicines to the usual treatment for Stage III lung cancer can reduce lung-related side effects and, importantly, improve your quality of life during and after your cancer treatment. It's about finding ways to make effective cancer treatment more gentle on your body.

Key takeaways

This study is for people with Stage III non-small cell lung cancer undergoing chemotherapy and radiotherapy.
It aims to see if two medicines, Pentoxifylline and Vitamin E, can reduce lung damage from treatment.
You would receive either the study medicines or a dummy pill, plus your standard cancer care.
The study hopes to improve your quality of life by reducing side effects.
Your health would be closely monitored throughout your participation.

Who may be eligible?

This study is looking for people who are aged 18 or older and have been diagnosed with Stage III non-small cell lung cancer. This particular type of lung cancer is inoperable, meaning surgery isn't an option, and you're planned to receive a standard course of treatment that includes chemotherapy, radiotherapy, and likely immunotherapy. You'll also need to be generally well enough to undergo these treatments.

To ensure your safety and the accuracy of the study, there are certain health conditions that would prevent you from taking part. For example, if you've recently had a heart attack, have ongoing serious bleeding, or a severe allergy to the study medications. Also, if you've received radiation to your chest for cancer in the past or are pregnant, you won't be able to join this particular study. If you're involved in another research study for a new medicine, you'll need to have finished that study at least six months before joining this one. Also, your liver and kidney function needs to be good enough, as shown by recent blood tests.

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 inoperable Stage III non-small cell lung cancer?
Are you planned to receive chemotherapy, radiotherapy, and immunotherapy?
Do you have good enough liver and kidney function?
Do you have a healthy heart and no active serious bleeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups, like flipping a coin. You have an equal chance (1 in 2) of being in either group. One group will receive the study medicines (Pentoxifylline and vitamin E), and the other group will receive dummy pills (placebos). You won't know which group you are in, nor will your doctor, which helps to ensure fair results. Both groups will continue to receive the standard cancer treatments for Stage III non-small cell lung cancer as planned by your medical team.

You will take the study medicines or dummy pills for six months. During this time, and potentially for a period after, you will have regular visits with the study team. These visits will involve health checks, blood tests, and possibly scans to monitor your health and how the treatment is affecting you and your cancer. The study will look closely at how your lungs are doing and how you are feeling overall to understand if the study medications are making a difference. The total duration of your involvement, including follow-up, will be discussed in detail by the study team.

Potential risks and benefits

Taking part in this study could potentially reduce the risk of developing lung problems from your cancer treatment, which might improve your quality of life. However, it's important to remember that these benefits are not guaranteed, as the study is designed to find out if the medications work. Any medicine can have side effects, and while Pentoxifylline and vitamin E are generally well-known, there could be individual reactions. The study team will monitor you closely for any side effects, particularly if you are taking blood-thinning medication. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care, and your decision will always be respected. This study is designed to be as safe as possible.

Locations (1)

University Health Network - Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada

Common questions

What is 'Stage III Non-Small Cell Lung Cancer'?

This is a type of lung cancer where the cancer has grown larger or spread to nearby lymph nodes, but hasn't spread to distant parts of the body.

What is 'Chemoradiation'?

This is a treatment that combines chemotherapy (medicines that kill cancer cells) and radiotherapy (high-energy rays to destroy cancer cells) given at the same time.

What is 'Pneumonitis'?

Pneumonitis is inflammation or irritation of the lung tissue. In this study, it refers to lung inflammation caused by radiotherapy.

What are 'Pentoxifylline' and 'Vitamin E'?

Pentoxifylline is a medicine that can improve blood flow and reduce inflammation. Vitamin E (alpha-tocopherol) is a well-known antioxidant that can help protect cells from damage. They are being studied together.

Why is this study 'double-blind'?

Double-blind means neither you nor your doctors will know if you are receiving the active study medicines or a dummy pill (placebo). This helps make sure the results are as fair and unbiased as possible.

How to find out more

Philip Wong MD

philip.wong4@uhn.ca 416-946-4501 Official trial record

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