Kirova, Y. M., Fromantin, I., De Rycke, Y., Fourquet, A., Morvan, E., Padiglione, S., . . . Bollet, M. A. (2011). Can we decrease the skin reaction in breast cancer patients using hyaluronic acid during radiation therapy? Results of phase III randomised trial. Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology, 100(2), 205–209.doi:10.1016/j.radonc.2011.05.014
To evaluate the benefit of hyaluronic acid in management of radiodermatitis
Women who developed a grade 1 dermatitis with radiotherapy were randomized to use either hyaluronic acid cream or a simple urea-based emollient once daily. Patients were advised to shower one-to-two times daily. Clinical evaluation of the skin was done weekly by the radiation oncologist. Pain and quality of life were assessed at the end of treatment on day 30. The study endpoint was a success as defined by disappearance of erythema 30 days after its occurrence.
The study used a randomised open-label phase III design.
Overall, 36.5% of participants withdrew prematurely because of worsening of eipthelitis, patient refusal, change in treatment, or use of another product. In the intent to treat population (all registered), there was a 27.3% treatment failure with hyaluronate and a 38.8% treatment failure with emollient. Power analysis showed that 100 per study group were needed. With drop outs, this study was underpowered.
The study did not demonstrate any significant differences in epithelitis between those using hyaluronic acid or emollient topically. The study was insufficiently powered to provide any firm conclusions.
Study findings are inconclusive because of the study limitations. Findings suggest that hyaluronic acid and urea-based emollients topically may provide similar results for prevention of low-grade radiodermatitis. These findings should be viewed with caution because of the study design limitations and lack of sufficient sample size to meet power requirements.