Randomized phase 2 trial of fullerene versus trolamine for reducing radiotherapy-related acute radiation dermatitis in head and neck cancer patients

Acute radiation dermatitis (ARD) is a common debilitating toxicity in patients undergoing radiotherapy (RT) for head and neck cancer (HNC). In a phase 2 trial at West China Hospital of Sichuan University (Chengdu, China), 132 HNC patients undergoing RT were randomized 1:1 to receive fullerene cream (n=66) or trolamine cream (n=66) three times daily from 3 days before to 14 after completion of RT. ARD was evaluated weekly from the start of RT to 4 weeks after completion of RT. The primary endpoint was incidence of grade ≥ 2 ARD. This incidence was significantly lower in the fullerene group than in the trolamine group, with 34.8% (95% CI 24.5-46.9) versus 83.3% (72.6-90.4) of patients developing grade ≥ 2 ARD. The authors conclude that fullerene significantly reduced the incidence of ARD compared with trolamine.