In a single-center phase II trial conducted in China and reported in the Journal of Clinical Oncology, Liu et al found that fullerene cream was superior to trolamine cream in reducing the risk of acute radiation dermatitis (ARD) in patients receiving definitive or adjuvant radiation therapy (RT) for nonmetastatic head and neck cancer. Trolamine is a traditional topical emulsion that supports skin hydration and wound healing, whereas fullerene functions as a potent antioxidant, directly scavenging radiation-induced free radicals.
Study Details
In the double-blind trial, 132 patients undergoing RT at West China Hospital, Sichuan University, were randomly assigned between August 2024 and March 2025 to apply fullerene cream (n = 66) or trolamine cream (n = 66) three times daily starting from 3 days before RT through 14 days after completion of RT. All patients received volumetric modulated arc therapy at a total dose of 60 to 72 Gy (1.8–2.2 Gy per fraction, five fractions per week). ARD was assessed weekly during and for 4 weeks after RT. The primary outcome measure was incidence of grade ≥ 2 ARD in the intention-to-treat population.
Key Findings
Grade ≥ 2 ARD was observed in 34.8% of patients (95% confidence interval [CI] = 24.5%–46.9%) in the fullerene group vs 83.3% of patients (95% CI = 72.6%–90.4%) in the trolamine group. In analysis adjusted for body mass index, diabetes, smoking, and concurrent chemotherapy, the adjusted relative risk for the fullerene group vs the trolamine group was 0.34 (95% CI = 0.22–0.52, P < .001). The median duration of grade ≥ 2 ARD was 14 days vs 28 days. Grade ≥ 3 ARD was observed in 6.1% vs 40.9% of patients (P < .001).
Treatment-related adverse events consisted of mild allergic reactions in three patients in the fullerene group (erythema, pruritus, and rash) and two patients in the trolamine group (pruritus and rash). No treatment-related serious adverse events were reported.
The investigators concluded: “In this prospective, randomized clinical trial, fullerene significantly reduced the incidence of ARD compared with trolamine.”
Xingchen Peng, MD, PhD, of the Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, China, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by the Noncommunicable Chronic Diseases–National Science and Technology Major Project, National Natural Science Foundation of China, and others. For full disclosures of the study authors, visit ascopubs.org.
