Mepitel Film Versus StrataXRT in Managing Radiation Dermatitis in an Intra-Patient Controlled Clinical Trial of 80 Postmastectomy Patients

IF 1.4 4区 医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING
Patries Herst, Mary van Schalkwyk, Natasha Baker, Rebecca Thyne, Kelly Dunne, Kylie Moore, Freya Jackson, Kendal Beaven, Lucy Rutten, Gemma McKee, Robin Willink, Melissa James
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引用次数: 0

Abstract

Background

Mepitel film decreases the severity of radiation dermatitis in breast cancer patients, but its application is resource-intensive. Many departments therefore use StrataXRT, a gel that patients apply themselves. We compared the protective effects of Mepitel film and StrataXRT on radiation dermatitis during and immediately after radiation therapy.

Methods

This phase III multicentre randomised intra-patient-controlled clinical trial recruited breast cancer patients receiving radiation therapy following mastectomy in three New Zealand Hospitals. Lateral and medial aspects of the chest wall were randomised to either Mepitel film or StrataXRT. Overall skin reaction severity was measured using RISRAS and RTOG once a week during treatment and for 4 weeks after treatment completion. The primary outcome was moist desquamation (with a non-inferiority margin of 7.5%); secondary outcomes were overall skin reaction severity, patient tolerability, satisfaction and cost.

Results

Between June 2021 and May 2024, 93 patients were recruited, and 80 patients completed the trial. The absolute difference in moist desquamation rates was 6% lower under Mepitel film (p = 0.413, 95% CI -5%, 18%). Overall skin reaction severity was significantly lower for Mepitel film (Researcher RISRAS: p = 0.022; RTOG: p = 0.011). Mepitel film was cheaper to apply but was less well tolerated, with poor skin adherence being an issue for many patients.

Conclusion

The study did not show non-inferiority for StrataXRT; overall skin reaction severity and costs were significantly lower under Mepitel film; however, StrataXRT was better tolerated.

Trial Registration: ACTRN12621000124831

Abstract Image

Mepitel膜与StrataXRT治疗放射性皮炎80例乳房切除术后患者的内部对照临床试验
背景:Mepitel膜可降低乳腺癌患者放射性皮炎的严重程度,但其应用耗费大量资源。因此,许多部门使用患者自行涂抹的凝胶StrataXRT。我们比较了Mepitel膜和StrataXRT在放射治疗期间和放疗后对放射性皮炎的保护作用。方法:这项III期多中心随机对照临床试验招募了在新西兰三家医院接受乳房切除术后放射治疗的乳腺癌患者。胸壁外侧和内侧随机分为Mepitel片或StrataXRT。在治疗期间和治疗结束后4周,使用RISRAS和RTOG每周一次测量总体皮肤反应严重程度。主要结局是湿性脱屑(非劣效裕度为7.5%);次要结果是总体皮肤反应严重程度、患者耐受性、满意度和成本。结果:在2021年6月至2024年5月期间,招募了93名患者,80名患者完成了试验。Mepitel膜下湿脱屑率的绝对差异降低了6% (p = 0.413, 95% CI -5%, 18%)。Mepitel薄膜的总体皮肤反应严重程度显著降低(RISRAS研究员:p = 0.022;RTOG: p = 0.011)。Mepitel薄膜的使用成本较低,但耐受性较差,许多患者的皮肤粘附性差。结论:该研究并未显示StrataXRT的非劣效性;Mepitel涂膜后皮肤反应严重程度和成本显著降低;然而,StrataXRT的耐受性更好。试验注册:ACTRN12621000124831。
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
3.30
自引率
6.20%
发文量
133
审稿时长
6-12 weeks
期刊介绍: Journal of Medical Imaging and Radiation Oncology (formerly Australasian Radiology) is the official journal of The Royal Australian and New Zealand College of Radiologists, publishing articles of scientific excellence in radiology and radiation oncology. Manuscripts are judged on the basis of their contribution of original data and ideas or interpretation. All articles are peer reviewed.
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