A trial looking at the effect of using a steroid cream to decrease the skin reactions caused by having radiotherapy

Who can enter

You can enter this trial if you

• Are having 3 to 4 weeks radiotherapy to the breast or chest wall
• Are male or female
• Are able to put on the skin cream yourself
• Are 18 years or older

You cannot enter this trial if you

• Have breast cancer that also affects your skin
• Have a skin wound that has not been treated
• Have a medical condition that could affect you taking part in this trial

Trial design

This trial will recruit 120 people. It is a randomised trial. The people taking part are put into one of two treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are put in or be told which group you are in. This is common in clinical trials and is called a double blind trial.

Half the people will have a tub of skin cream with a steroid in it to put on their skin.The other half will have a tub of skin cream with no steroid in it (placebo).

You put the cream on to the area where you have the radiotherapy. You do this once a day. You start when your radiotherapy starts and continue for 2 weeks after the end of your treatment. You can put the cream on any time of the day except in the 2 hours before your treatment.

You see one of the study team once a week during your radiotherapy treatment and for 2 or 3 weeks after you finish radiotherapy. You then hand back the tub that contained the cream.

You will be asked to fill in a couple of questionnaires

• Before you start radiotherapy
• Every week during radiotherapy
• Once a week for 2 or 3 weeks after radiotherapy

They will ask you about any symptoms you have in the treatment area and how you are feeling. This is called a quality of life study.

Hospital visits

You see the doctor before you start radiotherapy, and during radiotherapy. You also see a radiographer once a week to assess your skin reaction.

After treatment, you see the radiographer once a week for 2 or 3 weeks.

Side effects

The doctors think there will be no side effects from using the cream.

But there are side effects from radiotherapy to the breast. These may include

• Dry, Itchy , red and sore skin
• Discomfort and swelling of breast and chest area
• Tiredness

You can find more about radiotherapy skin reactions on CancerHelp UK.