Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized, double-blind, vehicle-controlled, multi-centre, parallel-group study to investigate the safety, tolerability, and efficacy of GR1014 cutaneous gel as a topical radioprotector in the prevention of the radiodermatitis occurring with adjuvant radiotherapy for localized breast cancer after lumpectomy

This study is testing a new skin gel called GR1014. It's designed for women having radiotherapy after breast cancer surgery (lumpectomy). Radiotherapy can sometimes cause skin irritation, redness, and pain, much like a severe sunburn – this is called radiodermatitis. Researchers want to find out if applying GR1014 gel to the skin can stop or lessen these side effects. They will compare it to a gel that looks the same but doesn't contain the active ingredient. The study will check how safe the gel is, how well people tolerate it, and if it's effective in preventing or reducing skin reactions. This is a Phase II study, meaning it's an early step to see if the gel works and is safe enough for further testing.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Graegis Pharmaceuticals Limited

Enrolment target

191

Start

21 May 2024

Radiation-induced dermatitis (radiodermatitis)

What is this study about?

When you have radiotherapy for breast cancer after a lumpectomy, the treatment uses high-energy rays to kill any remaining cancer cells. While this is very effective, these rays can sometimes affect healthy skin in the treated area. This can lead to a condition called radiodermatitis, where your skin can become red, sore, itchy, or even peel, similar to a bad sunburn. This can be uncomfortable and sometimes painful.

This study is looking at a new gel called GR1014. It's hoped that applying this gel to your skin during and after radiotherapy might help protect it from these side effects. Scientists are testing if this gel can reduce the chances of developing skin irritation, or make it less severe if it does happen. They are also checking how safe the gel is and if it causes any unwanted effects itself.

To see if the gel works, some participants will receive the active GR1014 gel, while others will receive a 'placebo' gel. The placebo gel looks exactly the same but doesn't contain the active medicine. This allows researchers to fairly compare the results and see if any improvements are genuinely due to the GR1014 gel rather than other factors. This is an important step in developing new treatments to improve the experience of people undergoing cancer therapy.

Key takeaways

This study is examining a new gel (GR1014) to prevent skin side effects from breast cancer radiotherapy.
It aims to reduce or completely stop skin irritation, pain, and redness (radiodermatitis).
Some participants will receive the active gel, others a dummy (placebo) gel.
You would apply the gel to the treated area during and after radiotherapy.
Doctors will closely monitor skin health and comfort throughout the study.
The study focuses on safety, how well the gel is tolerated, and its effectiveness.

Who may be eligible?

To join this study, you need to be a woman who is at least 18 years old. Importantly, you must be having radiotherapy for localized breast cancer after already having surgery called a lumpectomy. This means the study is specifically for women with breast cancer who are undergoing a particular type of follow-up treatment.

There will be other specific health requirements that the study doctors will check to make sure the study medication is safe for you and to ensure the results of the study are clear. For example, they might check your general health, other medications you are taking, and if you have any other skin conditions in the area that will be treated.

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?
Are you having radiotherapy for breast cancer?
Have you already had a lumpectomy (breast conserving surgery)?
Are you able to attend regular clinic visits during and after your radiotherapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be openly assigned to receive either the GR1014 gel or a placebo gel (which looks the same but contains no active medicine). Both you and your doctor would not know which gel you are receiving. You would apply the assigned gel to the area of your breast that is receiving radiotherapy. This would be done regularly throughout your radiotherapy sessions and for a period afterwards.

You would have several visits to the clinic, both during and after your radiotherapy. During these visits, the study team would carefully check your skin for any signs of irritation, redness, or pain. They would also ask you questions about any discomfort, itching, or pain you might be feeling, usually on a scale of 0 to 10. You might also fill out questionnaires about how your skin condition is affecting your everyday life. These assessments will help the researchers understand how well the gel is working and how safe it is. The study is expected to last for a few weeks, covering your radiotherapy treatment and up to 4 weeks after your last session.

Potential risks and benefits

Participating in a study means you might benefit from the new treatment if it works, or you might not. The gel is being tested because researchers believe it could help reduce skin reactions from radiotherapy, potentially making your treatment more comfortable. However, as with any new treatment, there could be side effects from the GR1014 gel itself, or from the placebo gel, though they aim to be minimal. The study team will monitor you closely for any unwanted effects. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is radiodermatitis?

Radiodermatitis is a common skin reaction, like a sunburn, that can happen when you have radiotherapy.

What is the GR1014 gel supposed to do?

The gel is being tested to see if it can protect your skin and reduce or prevent skin redness, pain, and irritation caused by radiotherapy.

Will I know if I'm getting the real gel or the dummy gel?

No, neither you nor your doctor will know if you are receiving the active GR1014 gel or the inactive (placebo) gel. This helps to make the study fair.

How long will I need to be in the study?

You will be in the study throughout your radiotherapy treatment and for about 4 weeks after your last radiotherapy session.

What happens if I want to stop taking part?

You can leave the study at any time you wish, and it won't affect your regular medical care.