A recent multi-center study in Southern Italy demonstrates that applying a wheat extract rigenase combined with polyhexanide spray significantly lowers the incidence of severe skin toxicity in breast cancer patients undergoing hypo-fractionated radiotherapy. Conducted across 15 centers, the research involved over three hundred patients to evaluate the effectiveness and safety of this topical treatment.
Study Design and Methodology
Involving 324 participants, the study administered rigenase and polyhexanide twice daily, beginning on the first day of radiotherapy and continuing for two weeks post-treatment. Patients were rigorously monitored with weekly skin assessments during the therapy and in the subsequent weeks, using the National Cancer Institute’s Common Toxicity Criteria to classify radiation-induced skin toxicity (RIST).
Key Findings and Patient Outcomes
The data revealed that about 24% of patients experienced grade 2 skin toxicity, predominantly appearing around the third week of radiotherapy. A smaller fraction, 4.5%, reported grade 3 toxicity during the same period. Notably, these adverse effects gradually diminished and were no longer present by the eighth week. Patients tolerated the treatment well, with minimal side effects such as mild itching reported by a few individuals.
- The combination treatment effectively delays and reduces the severity of acute RIST in a significant proportion of patients.
- Early intervention with rigenase and polyhexanide may enhance patient comfort and adherence to radiotherapy protocols.
- Minimal side effects suggest the treatment is safe for broader clinical use.
Implementing rigenase and polyhexanide as a preventive strategy in hypo-fractionated breast radiotherapy can significantly enhance patient quality of life by mitigating severe skin reactions. Healthcare providers should consider integrating this topical regimen into standard care protocols to reduce treatment-related dermatological complications without increasing patient burden.

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