The aim of this clinical trial recruiting in British Columbia and Ontario, Canada, is to determine the effectiveness of “intensity modulated radiation therapy” (IMRT) in large-breasted women lying facedown (prone) compared to those lying faceup (supine). The main outcome will be the rate of moist desquamation (a painful breakdown of the skin).
The details
A lumpectomy (or breast conserving surgery, removal of the tumor and some surrounding tissue only) is a surgical treatment for breast cancer that is often followed by radiation (uses high energy radiation to kill cancer cells by damaging their DNA). This decreases the chances of recurrent cancer (the return of the cancer). IMRT is a specific method of delivering radiation, and is often delivered with the patient lying on their backs. Women with a larger breast size are at more of a risk of developing a skin infection and breast pain following this treatment.
This study will measure whether rates of skin infection are lower in women treated with IMRT while lying face down. The main outcome will be measured through the rate of infection up to 8 weeks following treatment.
Who are they looking for?
The study aims to involve 378 women with breast cancer treated with breast conserving surgery and who are of a bra size of 40 inches or more (pre-surgery cup size of D or more).
Women are excluded from the study if they currently have a breast wound or skin infection. Women must be able to lie face down.
How will it work
Each woman is to receive 25 doses of the IMRT technique. They will be divided into two groups; in one group women will lie on their back and in the other group will lie face down.
Skin infections, breast pain and overall quality of life are to be observed following this treatment. This study will also assess whether the difference in position will change the dose distribution to other organs (heart, liver, lung and the second breast).
