Active not recruitingPHASE2INTERVENTIONAL

A Study of GR1014 Cutaneous Gel for the Prevention of Skin Reactions Caused by Radiation Therapy for Breast Cancer

This study is looking into a new skin gel, GR1014-CG, to see if it can protect skin from irritation caused by radiation therapy for breast cancer. Many women who have radiation after breast surgery develop red, sore, or itchy skin. This study wants to find out if this gel can help prevent or lessen these side effects. We are seeking women aged 18 and over who have had surgery for early-stage breast cancer and are about to start radiation. Participants will use one of two strengths of the study gel or a gel with no active medicine. The main goals are to check if the gel is safe and effective in reducing skin problems during radiation.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Graegis Pharmaceuticals Ltd

Enrolment target

273

Start

26 Jul 2024

Estimated completion

30 Oct 2026

Radiodermatitis; Acute

What is this study about?

When people have breast cancer, sometimes they need radiation therapy after surgery. While radiation is very good at stopping cancer from coming back, it can sometimes make the skin in the treated area red, sore, or itchy. This is called radiodermatitis, and it's a common side effect.

This study is testing a special gel called GR1014-CG. It contains an ingredient that has shown promise in protecting cells from radiation, and scientists believe it might help prevent or reduce these skin problems. By applying the gel to the skin before each radiation session, the researchers hope to stop the irritation from developing or make it less severe.

The main aim is to understand if GR1014-CG is safe to use and whether it works better than a gel without the active ingredient. Finding a way to protect the skin could make radiation therapy more comfortable for many women and improve their quality of life during treatment.

Key takeaways

This study evaluates a gel (GR1014-CG) to prevent skin irritation from breast cancer radiation.
It's for women after breast surgery who are receiving specific radiation therapy.
Participants will apply the gel before each radiation session.
The study checks the gel's safety and effectiveness in reducing skin problems.
You will have regular check-ups and keep a diary of skin symptoms.

Who may be eligible?

This study is for women who are at least 18 years old. You must have been diagnosed with early-stage breast cancer that hasn't spread, and you should have already had surgery to remove the tumour. Importantly, you need to be scheduled to receive a specific type of radiation therapy to your breast soon.

There are also some things that would mean you couldn't take part. For example, if you are pregnant or breastfeeding, or if you have certain skin conditions on your breast. You also can't join if you’ve had radiation to your chest area before, or if you're allergic to any ingredients in the gel. Your doctor will carefully check if you fit all the requirements.

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?
Have you had surgery for early-stage breast cancer?
Are you scheduled to receive radiation therapy to your breast?
Are you not pregnant or breastfeeding?
Do you have good general health?
Do you have no existing skin rash or open wounds on your breast area?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given one of two strengths of the study gel, or a gel that looks the same but doesn't contain the active medicine. This will be decided by chance, like flipping a coin. You'll apply the gel to your breast before each of your radiation sessions, for about five days.

Throughout the study, you'll visit the clinic once a week for four weeks so the doctors can check your skin and general health. If you still have skin irritation after four weeks, you might have one or two more follow-up visits. You'll also be asked to keep a simple diary to note down any pain or itching you feel. The total time you'd be actively involved in the study, including follow-up, would be about 6-8 weeks.

Potential risks and benefits

Participating in a study like this could potentially offer some benefits, such as receiving a gel that might help reduce skin irritation during radiation therapy. It also means you'll have close monitoring of your skin during this time. However, there's no guarantee the gel will work, and you might still experience skin irritation. As with any new medicine, there's always a chance of side effects, like an allergic reaction, though the study aims to check for safety. You are free to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (4)

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

Institut Bergonié
Verified postcode
Bordeaux, France
Centre Léon Bérard
Verified postcode
Lyon, France
Institut Gustave Roussy
Verified postcode
Villejuif, France
The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research
Verified postcode
Sutton, United Kingdom

Common questions

What is radiation-induced dermatitis?

It's skin irritation, like redness, soreness, or itching, that can happen after radiation therapy for cancer.

What is GR1014-CG?

It's a new gel being tested to see if it can protect your skin from the irritation caused by radiation therapy.

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

No, you won't know, and neither will your doctor. This helps make sure the results are fair and accurate.

How long will I be in the study?

You'll apply the gel during your radiation course (about 5 days), have weekly check-ups for 4 weeks, and possibly one or two more follow-up visits if needed, usually for a total of 6-8 weeks.

Will this study change my radiation treatment?

No, the study gel is applied in addition to your standard radiation therapy. Your radiation plan will not be changed.