Fullerene for Reducing Acute Radiation Dermatitis in Patients Undergoing Radiotherapy for Head and Neck Cancer: A Phase II, Double-Blind, Randomized Controlled Trial

Abstract

PURPOSE Acute radiation dermatitis (ARD) is a common debilitating toxicity in patients with head and neck cancer receiving radiotherapy. Current evidence-based strategies for preventing ARD remain limited, and alternative approaches are needed to optimize care. METHODS In this double-blind, randomized, controlled phase II trial, eligible patients with head and neck cancer undergoing radiotherapy were randomly assigned in a 1:1 ratio to receive either fullerene or trolamine at West China Hospital, Sichuan University, from August 2024 to March 2025. Participants were instructed to apply the assigned cream three times daily starting from the 3 days before radiotherapy and continuing for 14 days after completion of radiotherapy. ARD was evaluated weekly during radiotherapy and for 4 weeks after radiotherapy. The primary end point was the incidence of grade ≥2 ARD, assessed in the intention-to-treat population. RESULTS A total of 132 patients were randomly assigned, with 66 allocated to the fullerene group and 66 to the trolamine group. The patients had a mean age of 58.0 years (standard deviation, 11.1), and 39 (29.5%) were female. The incidence of grade ≥2 ARD was significantly lower in the fullerene group than in the trolamine group. In the fullerene group, 34.8% of patients (95% CI, 24.5 to 46.9) developed grade ≥2 ARD, compared with 83.3% of patients in the trolamine group (95% CI, 72.6 to 90.4). CONCLUSION In this prospective, randomized clinical trial, fullerene significantly reduced the incidence of ARD compared with trolamine.