Efficacy Study With StrataXRT for the Prophylaxis of Radiation Dermatitis in Adjuvant Breast Radiation Treatment in Large Breasted Women Using a Prone Technique
This study is investigating a new way to protect the skin during breast cancer radiotherapy for women with larger breasts. Radiotherapy can often cause skin irritation, redness, and sometimes even open sores, known as 'radiation dermatitis.' This can be uncomfortable and affect quality of life. Previous research showed that lying on your front during treatment (prone position) can reduce these skin issues compared to lying on your back. However, even in the prone position, some women still experience severe skin reactions. This study aims to see if a special silicone-based gel called StrataXRT, applied to the skin, can further lower the chances of these skin problems for women receiving radiotherapy while lying on their front. The goal is to make radiotherapy more comfortable and reduce side effects.
At a glance
What is this study about?
When you have radiotherapy for breast cancer, a common side effect is skin irritation in the treated area, similar to a bad sunburn. This is called radiation dermatitis. It can make your skin red, itchy, swollen, and sometimes even cause open sores, which can be very uncomfortable and affect your daily life.
For women with larger breasts, this irritation can be more common. Doctors have found that treating these women while they lie on their front (called the 'prone position') can help reduce the severity of these skin problems compared to lying on their back. While lying on your front does help, some women still experience significant skin issues.
This study is looking at a gel called StrataXRT. It's a special silicone-based gel that forms a flexible, protective layer on the skin. Previous smaller studies suggest that using this gel might further lower the chance of developing severe skin irritation and sores during radiotherapy, even for women treated in the prone position. The aim of this current study is to gather more information on how well StrataXRT works to protect the skin during breast cancer radiotherapy for women with larger breasts.
Key takeaways
- This study explores a gel (StrataXRT) to reduce skin irritation during breast cancer radiotherapy.
- It focuses on women with larger breasts treated while lying on their front (prone position).
- The goal is to prevent common skin side effects like redness and sores.
- StrataXRT is a silicone gel designed to create a protective barrier on the skin.
- Participation includes applying the gel and having your skin monitored.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you generally need to be an adult (18 years or older) and have breast cancer. You'll need to be scheduled for standard or slightly shortened courses of radiotherapy to your breast only, and this treatment must be given while you are lying on your front (prone position). Importantly, the study is for women with larger breasts, usually defined as a bra band size of 40 inches or more, or a cup size of D or larger.
There are also reasons why you might not be able to join. For example, if you can't comfortably lie on your front for the entire radiotherapy session, or if you've had radiotherapy to the same area before. You also couldn't join if you have a known allergy to silicone or if you're currently having certain types of chemotherapy. Additionally, if you have a skin rash or other skin condition in the treatment area that would make it hard to check your skin for the study, you might not be eligible. The study team will check all these details with you.
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?
- Are you having radiotherapy for breast cancer?
- Are you scheduled to have your radiotherapy lying on your front (prone position)?
- Do you have larger breasts (bra band size ≥40 inches or cup size ≥D)?
- Do you have any known allergies to silicone?
What does participation involve?
If you decide to take part in this study, you would receive the StrataXRT gel and instructions on how to apply it to your breast area before each radiotherapy session, as advised by the study team. You would attend your regular radiotherapy appointments, lying in the prone position as planned. Throughout your treatment, the study team would regularly check your skin reactions and record how well the gel is working to protect your skin. There may be follow-up appointments after your radiotherapy ends to continue monitoring your skin and any side effects. The total duration of your participation would cover your radiotherapy treatment and a period of follow-up.
Potential risks and benefits
Locations (1)
- Odette Cancer Centre, Sunnybrook Health Sciences CentreVerified postcodeToronto, Canada
Common questions
What is 'radiation dermatitis'?
It's a common skin reaction to radiotherapy, like a sunburn, causing redness, itchiness, and sometimes soreness in the treated area.
What does 'prone position' mean?
It means lying on your front during your radiotherapy treatment.
What is StrataXRT?
It's a silicone-based gel designed to form a protective layer on your skin, aiming to reduce skin irritation during radiotherapy.
Will I still get my normal radiotherapy treatment?
Yes, you will receive your standard breast cancer radiotherapy as planned, but with the added use of the StrataXRT gel.
Can I stop using the gel if it doesn't suit me?
Yes, you can stop using the gel and leave the study at any time without affecting your medical treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.