Active not recruitingNAINTERVENTIONAL

Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Breast Cancer Patients

This study aims to discover if a special dressing called Mepitel Film can prevent or reduce skin problems that often happen during radiotherapy for breast cancer. Many patients experience skin irritation, redness, and soreness, which can affect their quality of life. Current treatments haven't significantly improved in decades. Researchers previously found that Mepitel Film might help, and this larger study will compare it to the usual skin care provided to patients. Two out of three patients in the study will receive the film, while one in three will continue with standard care. This will help doctors understand if Mepitel Film is an effective new way to protect the skin during radiotherapy.

At a glance

Status

Active not recruiting

Phase

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

216

Start

30 Jan 2020

Estimated completion

01 Dec 2025

Breast Cancer Radiation Dermatitis

What is this study about?

When you have radiotherapy for breast cancer, it's very common for your skin in the treated area to become red, itchy, or sore, a bit like sunburn. This is called radiation dermatitis. Sometimes, it can become quite uncomfortable, and in some cases, it might even lead to a temporary pause in your treatment. These skin issues can be particularly noticeable for patients who have larger breasts or who are having radiotherapy to their chest wall. New ways to prevent or treat these skin reactions haven't been found for a long time.

Researchers have been looking into a special, clear film called Mepitel Film. Early studies have suggested that it might be helpful in stopping these severe skin reactions from developing. This new study is designed to get more clear evidence to see if Mepitel Film is genuinely better than the skin care that's usually given to patients during radiotherapy. If it proves to be effective, it could offer a new way to make radiotherapy more comfortable for many people.

The study will involve patients with breast cancer who are having radiotherapy. Patients will be randomly put into two groups: one group will use the Mepitel Film, and the other will use the usual skin treatments. All patients will have their skin carefully checked throughout their treatment. This will help the doctors compare how well the film works against current practices. This information is important because it could lead to changes in how skin is cared for during radiotherapy, making a real difference to patients' experiences.

Key takeaways

This study investigates a film (Mepitel Film) to prevent common radiotherapy skin problems.
It aims to make radiotherapy more comfortable for breast cancer patients.
Patients are randomly assigned to either use the film or standard skin care.
The study assesses if the film reduces redness, soreness, and other skin reactions.
It's especially interested in patients with larger breasts or chest wall radiotherapy.

Who may be eligible?

This study is looking for both men and women aged 18 or over who have breast cancer and are scheduled to receive radiotherapy after surgery (either a mastectomy or breast-conserving surgery). If you've had a mastectomy, you might be eligible. If you've had breast-conserving surgery, you're more likely to be eligible if you have larger breasts (typically a bra size of 36 inches and/or a C cup or larger).

You wouldn't be able to join this study if you've had radiotherapy on the same area before, if you have a skin rash or irritation in the treatment area already, or if you know you're allergic to sticky dressings or silicone. Also, those having certain other treatments like a type of internal radiotherapy called brachytherapy, or those having chemotherapy at the same time, would not be suitable. It's also not for individuals with inflammatory breast cancer or if the cancer is clearly affecting the skin at the start of radiotherapy.

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 breast cancer and are you scheduled for radiotherapy after surgery?
If you had breast-conserving surgery, do you have larger breasts (e.g., bra size 36 and/or C cup or more)?
Have you *not* had radiotherapy on the same area before?
Do you *not* have a current skin rash or allergy to sticky dressings in the treatment area?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first be randomly assigned to one of two groups. Two out of three patients will use the Mepitel Film on their skin in the treated area, while the remaining one out of three will receive the standard skin care typically offered by the hospital. You'll be asked to follow the instructions for your assigned skin care routine throughout your radiotherapy.

Throughout your radiotherapy treatment, your skin will be regularly checked by the study team to see how it's reacting and to note any changes. This assessment will involve close examination of the skin in the treated area. The total duration of your participation in the study will cover your entire course of radiotherapy, plus any follow-up assessments needed to monitor the skin's healing and long-term condition. You won't have extra hospital visits beyond what's needed for your radiotherapy and the study's skin assessments.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new type of skin protection that might reduce severe skin reactions during radiotherapy, which could make your treatment more comfortable. However, there's no guarantee that the Mepitel Film will work for everyone, and it's possible that your skin reaction could be similar to or, in rare cases, worse than with standard care. There's also a small chance of skin irritation or allergy from the film itself. You are completely free to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada

Common questions

What is Mepitel Film?

Mepitel Film is a clear, thin dressing that's designed to protect the skin. It's being tested to see if it can help prevent skin problems during radiotherapy.

Will I know if I'm getting the Mepitel Film or standard care?

You will be told which group you are in. Two out of three people will use the film, and one in three will use the usual skin care provided by the hospital.

What are 'radiation-induced skin reactions'?

These are skin problems caused by radiotherapy, like redness, soreness, itching, or peeling, similar to a sunburn. They are also known as radiation dermatitis.

Can I still have my regular breast cancer treatment if I join?

Yes, this study is designed to run alongside your planned radiotherapy. It won't change your main cancer treatment.

What happens if I get a bad skin reaction while in the study?

Your skin will be carefully monitored throughout the study. If you experience any severe reactions, the study team will provide appropriate care and you can withdraw from the study at any time.