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

Current evidence-based strategies for preventing ARD remain limited, and alternative approaches are needed to optimize care.

目前，预防ARD的循证策略仍然有限，需要其他方法来优化护理。

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.

在这项双盲、随机、对照的II期临床试验中，符合条件的头颈部癌症患者在进行放射治疗时，按照1:1的比例随机分配接受富勒烯或曲酸胺治疗，该试验在四川大学华西医院进行，从2024年8月到2025年3月。

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.

参与者被指示从放射治疗前3天开始，每天三次涂抹所分配的乳膏，并持续至放射治疗完成后的14天。

ARD was evaluated weekly during radiotherapy and for 4 weeks after radiotherapy.

放疗期间每周评估一次ARD，并在放疗后4周内继续评估。

The primary end point was the incidenceof grade ≥2 ARD, assessed in the intention-to-treatpopulation.

主要终点是评估意向治疗人群中≥2级ARD的发生率。

Results

A total of 132 patients were randomly assigned, with 66 allocated to the fullerene group and 66 to the trolamine group.

共有132名患者被随机分配，其中66名被分配到富勒烯组，66名被分配到曲拉明组。

The patients had a mean age of 58.0 years (standard deviation, 11.1), and 39 (29.5%) were female.

患者的平均年龄为58.0岁（标准差，11.1），其中39名（29.5%）为女性。

The incidenceof grade ≥2 ARD was significantly lower in the fullerene group than in the trolamine group.

富勒烯组中2级及以上急性放射性皮肤损伤的发生率显著低于三乙醇胺组。

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).

在富勒烯组中，有34.8%的患者（95%置信区间，24.5至46.9）发展出2级及以上急性放射性皮肤损伤，而在三乙醇胺组中这一比例为83.3%（95%置信区间，72.6至90.4）。

Conclusions

In this prospective, randomized clinical trial, fullerene significantly reduced the incidenceof ARD compared with trolamine.

在这项前瞻性、随机临床试验中，富勒烯显著降低了急性呼吸窘迫综合征（ARD）的发生率，与曲拉明相比。