Pardo Masferrer, J., Murcia Mejía, M., Vidal Fernández, M., Alvarado Astudillo, A., Hernández Armenteros, M. L., Macías Hernández, V., . . . Mirada Ferre, A. (2010). Prophylaxis with a cream containing urea reduces the incidence and severity of radio-induced dermatitis. Clinical and Translational Oncology, 12, 43–48.
Primary Aim: To evaluate the effectiveness of author-defined intensive use (three times daily [TID] use starting two or three weeks before radiotherapy [RT] and continuing this frequency throughout RT) application of a lotion preparation made of 3% urea, polidocanol, and hyaluronic acid for preventing the appearance of acute radiodermatitis and controlling its severity in patients actively undergoing RT for breast cancer.
Secondary Aim: To study effectiveness, the authors compared the incidence and grade of toxicity with 174 patients with breast cancer treated in the same clinic the previous year. These patients used skin-support measures at the beginning of RT or when radiodermatitis occurred.
Ureadin cream was used TID for two to three weeks prior to the start of external beam RT (EBRT) and continued for the entire treatment period. This use was considered intensive compared to other studies and the standard use schedule of twice daily (BID) cream application at the start of RT or 10 days before starting RT.
This was a prospective, observational study performed over 14 months.
The overall rate of radiodermatitis was 72.4%, with 51% of patients being toxicity grade 1; 20% grade 2, and 1% grade 3. The first case of skin toxicity appeared in third week of treatment; in >87% of patients, radiodermatitis appeared between weeks 5 and 7. The severity of radiodermatitis with the intensive use of the lotion was significantly lower (72.4% vs. 84.5%; p < 0.05). The grade of toxicity was significantly lower in intensive-use patients (p < 0.001), and grade 2 toxicity or higher was significantly lower (21.4% vs. 50%; p < 0.01). Severity of clinical symptoms of pain, itching, redness, desquamation, and impact on QOL was reported as negligible by patients.
For patients with breast cancer who undergo conservative surgery and will receive RT to a dose of 60 to 70 Gy, use of Ureadin on an intensive basis (TID beginning two to three weeks prior to the start of RT) compared to BID use is considered effective at reducing the incidence and grade of skin toxicity during RT and is well tolerated by patients.