A randomised controlled pilot trial of Argentum/Urtica comp. Gel for prevention and management of radiation dermatitis in breast cancer

Radiation dermatitis (RD) is a frequent adverse effect of breast cancer radiotherapy that can impair quality of life and disrupt treatment. Evidence supporting any single topical preventive intervention remains limited. This pilot randomised controlled study explored whether Argentum/Urtica comp. Gel influences RD severity and patient-reported symptoms compared with standard skin care, and aimed to generate effect estimates for future trials. Patients undergoing breast radiotherapy were randomised to Argentum/Urtica comp. Gel or standard care (Excipial-Hydrolotion). Outcomes included physician-assessed RD severity (extended CTCAE), rescue-care use, and patient-reported outcomes (VAS, Skindex-16, FACIT-TS-G). No adjustment for multiple testing was performed. Thirty patients were randomised; 28 were included in the primary analysis. No difference in maximum acute RD severity was observed (median CTCAE 1.7 in both groups). Rescue-care use was 31% (95% CI: 13–58%) in the Argentum/Urtica comp. Gel group and 69% (95% CI: 42–87%) in the standard-care group (χ² = 5.073, p = 0.020). Given the open-label design, clinician-driven escalation, small sample, and multiple testing, this finding should be interpreted cautiously and may reflect bias or chance. Trends toward lower pain and itch did not reach statistical significance. No relevant differences were observed in Skindex-16 or FACIT-TS-G. The primary endpoint was not met. The observed difference in rescue-care use is exploratory and hypothesis-generating. Larger, blinded trials with predefined escalation criteria are required. NCT03494205 Register: Clinicaltrials.gov