A study about the S4A support bra for women having radiotherapy for breast cancer

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Pilot
This study is for women who had surgery to remove breast cancer (conservative surgery) and are going to have radiotherapy to their breast. The cancer may or may not have spread to the lymph nodes but has not spread to other parts of the body.
 
Radiotherapy is a treatment to try to stop the breast cancer coming back.

More about this trial

When women have radiotherapy after surgery for breast cancer they are naked to the waist. They also need to have around 3 small tattoos on the skin (like a pin head) to show the radiographers where to target the radiotherapy each time you have treatment. 
 
Side effects of radiotherapy can include skin problems.
 
Radiotherapy can also affect important organs near to the breasts such as the heart and the lungs. Researchers have designed a support bra to be worn during radiotherapy treatments. They think it might have particular benefit for women with either:
  • Large breasts
  • Breasts that hang low on the chest (can be more common in older people)

Researchers are always looking for ways to improve treatment and reduce side effects. This study aims to see if the support bra can:

  • hold the breast securely to reduce radiation to nearby organs (such as the heart and the lungs)
  • help radiographers to target radiotherapy more accurately
  • reduce skin problems on the breast 
  • maintain dignity,and help women to feel less self conscious when they are having treatment

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 
 
Who can take part
 
You may be able to join this study if all of the following apply. You
  • have invasive breast cancer which may or may not have spread to the lymph nodes but has not spread to another part of the body
  • had surgery to remove cancer but still have a breast (conservative surgery)
  • are having radiotherapy to the whole breast
  • have a bra cup size of at least 28F/30E/32DD/34D/36C
  • aged 18 or over 
Who can’t take part
 
You cannot join this study if any of these apply. You
  • had previous breast cancer (including ductal carcinoma in situ or DCIS)
  • are having chemotherapy at the same time as radiotherapy (you might   be able to take part if you are having chemotherapy after radiotherapy) 
  • are having radiotherapy to your lymph nodes 
  • are having an extra dose to the site of the cancer (tumour bed) 

Trial design

This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor can decide which group you are in. 
 
Everybody taking part is put into 1 of 2 groups at random. Researchers need 50 women to take part. 
 
Group 1
 
People in group 1 will have 1 planning scan at the planning appointment. You will have up to 3 small tattoos on the skin to show the target for the radiotherapy.
 
Your treatment will be the same as the standard treatment. 
 
Group 2 
 
People in group 2 will have two planning scans at the planning appointment. One scan will be:
  • with the support bra 
  • without the support bra 
You wear the support bra for each radiotherapy treatment. 
 
You might only need 1 or 2 tattoos on the skin to show the target for the radiotherapy.
 
Trial diagram
 

Quality of Life questionnaires 

The questionnaires will ask about side effects and how you’ve been feeling. They are called quality of life questionnaires. The researchers will ask you to fill in the first questionnaires at your radiotherapy planning appointment. 

You will complete questionnaires each week of radiotherapy and at the end of your treatment. 

Questionnaires can be completed at hospital appointments or you can fill them in at home and post them back to the trial team. 

Hospital visits

You do not need to attend any additional appointments if you take part in this study.

Side effects

Group 1 

People in group 1 will have the same side effects as people having standard radiotherapy treatment. 

Read about the side effects of radiotherapy

Group 2 

People in group 2 will have an extra scan at the radiotherapy planning appointment. The extra radiation is very small. The study team can discuss this with you. 

Some women may have increased skin problems from the bra.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Gillian Brown

Supported by

Sheffield Hallam University 
NIHR Invention for Innovation (i4i) Programme

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15025

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."

Last reviewed:

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