Urtica comp. gel for prevention and therapy of radiation dermatitis An interdisciplinary, interprofessional phase II randomized controlled trial in patients with breast cancer

Purpose: Radiation dermatitis (RD) is one of the most common side effects of radiotherapy for breast cancer and affects 90 % of patients. Skin lesions bear a marked risk of infection and have a profound impact on the patient’s quality of life, due to pain and discomfort. This can cause interruption to radiotherapy, resulting in inadequate disease treatment. The aim was to test if Urtica comp. gel reduces the incidence and severity of RD, reduce the need for additional therapy, pain, and improve the quality of life. Methods: A randomised open-label phase II study compared Urtica comp. gel with the standard of care, Excipial-Hydrolotion. Patients were assessed at baseline, at weekly assessments and up to 6 weeks after radiotherapy. Results: A total of 30 patients were randomly assigned and included. There was no statistically significant difference in maximum acute RD between Urtica comp. gel and Excipial-Hydrolotion. However, Urtica comp. gel significantly reduced the need for rescue care with only 31 % of the 13 patients needing rescue care compared to 69 % using Excipial-Hydrolotion. A chi-square test of independence found that the relationship was highly significant, X ² (1, N =28) = 5.073 , p = 0.02 . Results also showed a trend for reduced pain (Cohen's d = 0.74, p = 0.09) and itchiness (not significant Cohen's d = 0.57, p=0.16) on the Visual Analog Scale (VAS) for patients receiving Urtica comp. gel. In addition, patients using Urtica comp. gel rated the appearance of their RD as significantly better than patients receiving Excipial-Hydrolotion (p < 0.02, p < 0.03, p < 0.02) in week 3, 4 and 5 respectively. There were no major differences between groups on skin-related quality of life. Conclusion: This study yielded promising results and found that Urtica comp. gel was statistically more effective than standard of care in reducing the need for rescue care in patients undergoing radiotherapy. Patients also rate the appearance of their RD as significantly better when using Urtica comp and scored lower pain and itchiness on the VAS. These results highlight that Urtica comp. gel may be an effective treatment option against RD. This should be further tested in a larger clinical trial. Trial Registration NCT03494205