Fullerene for Reducing Acute Radiation Dermatitis in Patients Undergoing Radiotherapy for Head and Neck Cancer: A Phase II, Double-Blind, Randomized Controlled Trial - PubMed
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- #Head and Neck Cancer
- #Radiation Dermatitis
- #Fullerene
- Study evaluates fullerene's efficacy in reducing acute radiation dermatitis (ARD) in head and neck cancer patients undergoing radiotherapy.
- Phase II, double-blind, randomized controlled trial comparing fullerene with trolamine.
- 132 patients randomized (66 fullerene, 66 trolamine), mean age 58.0 years, 29.5% female.
- Fullerene group showed significantly lower incidence of grade ≥2 ARD (34.8%) vs. trolamine (83.3%).
- Application protocol: cream applied three times daily, starting 3 days before radiotherapy and continuing for 14 days post-radiotherapy.
- Primary endpoint: incidence of grade ≥2 ARD, assessed in intention-to-treat population.
- Conclusion: Fullerene significantly reduces ARD incidence compared to trolamine.