Randomized Pilot Study of a Keratin-based Topical Cream for Radiation Dermatitis in Breast Cancer Patients.

IF 2.7 4区 医学 Q3 ONCOLOGY
Karen M Winkfield, Ryan T Hughes, Doris R Brown, Ryan M Clohessy, Robert C Holder, Gregory B Russell, Alexis F Rejeski, Luke R Burnett
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引用次数: 0

Abstract

Purpose: Radiotherapy (RT) is commonly used in the treatment of breast cancer and often, despite advances in fractionated dosing schedules, produces undesirable skin toxicity. The purpose of this study was to evaluate the feasibility of using a keratin-based topical cream, KeraStat® Cream (KC; KeraNetics, Inc., Winston Salem, NC, USA) to manage the symptoms of radiation dermatitis (RD) in breast cancer patients undergoing RT. Materials and Methods: A total of 24 subjects were enrolled on this single-center, randomized, open-label study. Participants were randomly assigned to KC or standard of care (SOC, patient's choice of a variety of readily available creams or moisturizers). Patients were asked to apply the assigned treatment to the irradiated area twice daily, beginning with day 1 of RT, through 30 days post-RT. The primary outcome was compliance of use. Secondary outcomes included safety and tolerability of KC, as well as RD severity assessed using the Radiation Therapy Oncology Group (RTOG) scale and the patient-reported Dermatology Life Quality Index (DLQI). Results: All subjects in the KC group were assessed as compliant with no adverse events. The rate of RTOG Grade 2 RD was lower in the KC group (30.8%) compared to the SOC group (54.5%, P = .408). At the final RT visit, the mean RTOG RD score was lower in the KC group (1.0) versus the SOC group (1.4). Similarly, patient-reported quality of life measured by the DLQI at the end of RT was improved in the KC group (mean 4.25, small effect) versus the SOC group (mean 6.18, moderate effect, P = .412). Conclusions: KC was safe and well tolerated with no adverse events. Though efficacy measures were not powered to draw definitive conclusions, trends and clinical assessments suggest that there is a benefit of using KC compared to SOC for breast cancer patients treated with RT, and a larger powered study for efficacy is warranted. Trial Registry: This clinical trial is registered as NCT03374995 titled KeraStat(R) Cream for Radiation Dermatitis.

治疗乳腺癌患者放射性皮炎的角蛋白外用药膏随机试验研究
目的:放疗(RT)是治疗乳腺癌的常用方法,尽管在分次给药计划方面取得了进步,但经常会产生不良的皮肤毒性。本研究旨在评估使用角蛋白外用乳膏 KeraStat® Cream(KC;KeraNetics, Inc.,美国北卡罗来纳州温斯顿塞勒姆)治疗接受 RT 治疗的乳腺癌患者放射性皮炎(RD)症状的可行性。材料与方法:共有 24 名受试者参加了这项单中心、随机、开放标签研究。受试者被随机分配到 KC 或标准护理(SOC,患者可选择各种现成的药膏或保湿霜)。要求患者从 RT 开始的第 1 天到 RT 后的 30 天内,每天两次在照射区域涂抹指定的治疗药物。主要结果是使用的依从性。次要结果包括 KC 的安全性和耐受性,以及使用肿瘤放疗组 (RTOG) 量表和患者报告的皮肤科生活质量指数 (DLQI) 评估的 RD 严重程度。结果KC 组的所有受试者均被评估为符合要求,无不良反应。KC 组的 RTOG 2 级 RD 发生率(30.8%)低于 SOC 组(54.5%,P = .408)。在最后一次 RT 检查中,KC 组的 RTOG RD 平均得分(1.0)低于 SOC 组(1.4)。同样,在 RT 结束时,以 DLQI 衡量的患者报告生活质量在 KC 组(平均 4.25,小效应)比 SOC 组(平均 6.18,中度效应,P = .412)有所改善。结论:KCKC 安全且耐受性良好,无不良反应。虽然疗效测量结果并不能得出明确的结论,但趋势和临床评估表明,对于接受 RT 治疗的乳腺癌患者,与 SOC 相比,使用 KC 有一定的益处,因此有必要进行更大规模的疗效研究。试验登记:该临床试验登记为 NCT03374995,名为 "治疗放射性皮炎的 KeraStat(R) 乳霜"。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.40
自引率
0.00%
发文量
202
审稿时长
2 months
期刊介绍: Technology in Cancer Research & Treatment (TCRT) is a JCR-ranked, broad-spectrum, open access, peer-reviewed publication whose aim is to provide researchers and clinicians with a platform to share and discuss developments in the prevention, diagnosis, treatment, and monitoring of cancer.
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