RecruitingPHASE3INTERVENTIONAL

Topical Betamethasone Versus Moisturizer in Preventing Radiation Dermatitis in Large-Breasted Patients Treated in the Prone Position

Radiation treatment for breast cancer can often cause skin redness, itching, and soreness, known as radiation dermatitis. Women with larger breasts are particularly at risk. This study investigates if a common anti-inflammatory cream called betamethasone can help prevent or reduce this skin reaction. It specifically looks at patients with large breasts who receive their radiation treatment while lying on their front (the prone position). Researchers want to see if adding betamethasone to their usual skincare routine can further reduce skin problems compared to just using moisturiser. This could make radiation treatment more comfortable and easier to complete for many women.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

276

Start

26 Feb 2025

Estimated completion

06 Dec 2026

Breast Cancer Radiation Dermatitis

What is this study about?

When you have radiation treatment for breast cancer, it's very common to experience skin irritation in the treated area, similar to a bad sunburn. This is called radiation dermatitis, and it can cause redness, itching, swelling, and sometimes even broken skin. For women with larger breasts, this can be an even bigger problem, affecting their comfort and sometimes making it harder to finish all their treatments.

Doctors have already found that lying on your front (the prone position) during radiation can help reduce these skin problems compared to lying on your back. However, about one in four women still get bothersome skin reactions. There are also special films that can protect the skin, but they don't work well for all patients, especially those treated in the prone position, and they can be expensive.

This study is looking at a common anti-inflammatory cream called betamethasone. It's affordable and has been shown in other studies to reduce skin irritation when people are treated lying on their back. The doctors believe that if women with larger breasts who are having radiation in the prone position also use betamethasone cream, it could further lower their chances of getting severe skin irritation. This trial is the first of its kind to compare betamethasone with standard moisturisers in this specific group of patients.

Key takeaways

This study is for women with breast cancer who have larger breasts.
It aims to reduce skin reactions from radiation treatment (radiation dermatitis).
It compares betamethasone cream to standard moisturiser.
Participants will receive radiation treatment while lying on their front.
The study involves regular skin checks and questionnaires.
Your general medical care will not be affected if you choose not to join.

Who may be eligible?

To join this study, you would need to be a woman aged 18 or older who has been diagnosed with breast cancer. You must have larger breasts, meaning your bra size is 40 inches or more, or a D cup or larger. You also need to be scheduled to receive your radiation treatment for breast cancer while lying on your front (prone position).

There are some reasons why you might not be able to join. For example, if you've already had radiation treatment to the same area, or if you're planning to have a different type of radiation therapy called brachytherapy. If you have an active rash or skin condition in the treatment area, or if you're taking certain chemotherapy drugs at the same time, you wouldn't be able to participate. Also, if you can't tolerate lying in the prone position or have an allergy to betamethasone, you wouldn't be suitable. The study also cannot include pregnant women.

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 a woman aged 18 or older?
Do you have a bra size of 40 inches or more, or a D cup or larger?
Are you having radiation treatment for breast cancer?
Will you be treated lying on your front (prone position)?
Do you have any active rash or skin condition in the treatment area?
Are you currently pregnant or planning to become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to either use betamethasone cream or your usual moisturiser (standard care) on your treated breast area. You'll apply this cream daily, starting from the first day of your radiation treatment until two weeks after your last treatment session.

Over this period, you'll have regular check-ups. This includes weekly appointments during your radiation treatment and a follow-up appointment two weeks after your treatment finishes. You'll also have a few more checks over the next six weeks and a final check-up over the phone three months after your treatment ends. Your skin will be examined, and photos might be taken. You'll also be asked to complete questionnaires about your skin symptoms, how your skin reaction affects your daily life, and how satisfied you are with your treatment.

Potential risks and benefits

The potential benefits of joining this study include the possibility of experiencing less severe skin irritation and discomfort during and after your breast cancer radiation treatment. The anti-inflammatory cream might help protect your skin better than standard moisturiser. As with any medication, there's a small chance of side effects from betamethasone, although topical application usually leads to minimal side effects. You are free to withdraw from the study at any time for any reason, and your medical care will not be affected regardless of your decision.

Locations (1)

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

Common questions

What is radiation dermatitis?

It's skin irritation, like a sunburn, that can happen after radiation treatment. It can cause redness, itching, and soreness.

Why are women with larger breasts more at risk?

The skin folds and increased surface area in larger breasts can make them more prone to irritation from radiation.

What is betamethasone?

It's a common anti-inflammatory cream, often used to reduce swelling and redness.

Will I definitely get betamethasone if I join?

No, you'll be randomly assigned to either use betamethasone cream or a standard moisturiser. It's like flipping a coin for which group you're in.

How long will I be involved in the study?

You'll use the cream during your radiation treatment and for two weeks after, with follow-up appointments extending to three months after treatment.

How to find out more

Edward LW Chow, MBBS

edward.chow@sunnybrook.ca 416-480-4974 Official trial record

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