A Multicentre Randomized Controlled Clinical Trial for the Reduction of Acute Skin Reaction in Adjuvant Breast Radiation in Large Breasted Women Using a Prone Technique - The Prone Breast Trial
The risk of moist desquamation in large breasted women remains unacceptably high and
reactions tends to be severe and produce significant permanent and delayed side effects.
Evidence suggests that the use of a prone breast IMRT technique has the potential to
decrease the risk of moist desquamation in large breasted women to the levels that are now
seen when average/smaller breasted women are treated with supine IMRT. As prone breast XRT
is currently only offered at 6 of 15 of the Ontario Cancer Centres polled for the purposes
of providing motivation for this study, a multicentre RCT is feasible to confirm and
quantify the improvement provided by the prone technique and provide Level 1 evidence for it
to be adopted world-wide.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Acute moist desquamation rates as measured by CTCAE 4.03 during and up to 6-8 weeks post treatment.
6-8 week post-treatment.
Danny Vesprini, MD MSc FRCPC
Sunnybrook Odette Cancer Centre
Canada: Health Canada