Hughes Ryan T, Levine Beverly J, Frizzell Bart A, Greven Kathryn M, Porosnicu Mercedes, Lycan Thomas W, Burnett Luke R, Winkfield Karen M
Department of Radiation Oncology, Wake Forest University School of Medicine, Winston Salem, NC, USA.
Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston Salem, NC, USA.
J Radiother Pract. 2024;23. doi: 10.1017/s1460396924000037. Epub 2024 Apr 15.
Radiation dermatitis (RD) is a frequent toxicity during radiotherapy (RT) for head and neck cancer (HNC). We report the first use of KeraStat Cream (KC), a topical, keratin-based wound dressing, in patients with HNC receiving RT.
This pilot study randomized HNC patients treated with definitive or postoperative RT (≥60 Gy) to KC or standard of care (SOC), applied at least twice daily during and for 1-month after RT. Outcomes of interest included adherence to the assigned regimen (at least 10 applications per week of treatment), clinician- and patient-reported RD, and skin-related quality of life.
24 patients were randomized and completed the study. Most patients had stage III-IV disease and oropharynx cancer. Median RT dose was 68 Gy; the bilateral neck was treated in 19 patients, and 18 patients received concurrent chemotherapy. Complete adherence was observed in 7/12 (SOC) vs. 10/12 (KC, = 0.65). Adherence by patient-week was 61/68 versus 64/67, respectively ( = 0.20). No differences in RD were observed between groups.
A randomized trial of KC versus SOC in HNC patients treated with RT is feasible with good adherence to study agent. An adequately powered randomized study is warranted to test the efficacy of KC in reducing RD.
放射性皮炎（RD）是头颈癌（HNC）放射治疗（RT）期间常见的一种毒性反应。我们报告了首次在接受放疗的头颈癌患者中使用KeraStat乳膏（KC），这是一种局部使用的、基于角蛋白的伤口敷料。
这项前瞻性研究将接受根治性或术后放疗（≥60 Gy）的头颈癌患者随机分为KC组或标准治疗（SOC）组，在放疗期间及放疗后1个月内每天至少使用两次。感兴趣的结果包括对指定治疗方案的依从性（每周至少10次治疗应用）、临床医生和患者报告的放射性皮炎情况以及与皮肤相关的生活质量。
24例患者被随机分组并完成研究。大多数患者患有III-IV期疾病和口咽癌。放疗中位剂量为68 Gy；19例患者双侧颈部接受治疗，18例患者接受同步化疗。观察到完全依从性在SOC组为7/12，KC组为10/12（P = 0.65）。按患者周计算的依从性分别为61/68和64/67（P = 0.20）。两组之间在放射性皮炎方面未观察到差异。
在接受放疗的头颈癌患者中进行KC与SOC的随机试验是可行的，对研究药物的依从性良好。有必要进行一项有足够样本量的随机研究来检验KC在减少放射性皮炎方面的疗效。
