Dermatitis is a common side effect of radiotherapy (RT). L. leaves () exhibit anti-inflammatory and wound-healing activities. This study aimed to evaluate the preventive effect of on acute radiodermatitis in breast cancer patients. This randomized controlled trial involved 78 breast cancer patients who had undergone modified radical mastectomy and were scheduled for RT. After random allocation, the control group ( = 39) received a placebo and the intervention ( = 39) group received cream. It was used as an external application twice per day from the first day of RT until two weeks after the completion of the radiation course. The patients were examined weekly by a physician. The primary outcome was the incidence and severity of acute radiodermatitis, graded according to Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) and National Center Institute Common Terminology Criteria for Adverse Events, version 5 (NCI-CTCAE) toxicity scoring systems. Radiodermatitis grades ≥2 according to the RTOG/EORTC and NCI-CTCAE scoring systems developed from the third week of RT, peaking in the sixth week in both groups. The incidence of grades ≥2 acute dermatitis was lower in patients treated with topical than with the placebo (51.3% vs. 66.7%), but this difference was not statistically significant (relative risk = 0.769, 95% confidence interval, 0.429–1.373). Dermatitis grades ≥2 had no relationship with body mass index ≥30 and older age. Itching during the six weeks of follow-up was more common in the group. This study revealed that 7% cream did not significantly decrease the severity of acute radiodermatitis. Conducting multicenter trials with larger sample sizes and using different topical agents based on are recommended for future studies. IRCT20150830023823N4.

中文翻译：

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车前子大叶提取物霜与安慰剂相比在预防乳腺癌患者急性放射性皮炎方面的功效：一项随机临床试验


皮炎是放射治疗 (RT) 的常见副作用。 L. leaves () 具有抗炎和伤口愈合活性。本研究旨在评估对乳腺癌患者急性放射性皮炎的预防作用。这项随机对照试验涉及 78 名接受改良根治性乳房切除术并计划接受 RT 的乳腺癌患者。随机分配后，对照组 (= 39) 接受安慰剂，干预组 (= 39) 接受乳膏。从放疗第一天到放射疗程完成后两周，每天两次外用。医生每周对患者进行一次检查。主要结果是急性放射性皮炎的发生率和严重程度，根据放射治疗肿瘤学组和欧洲癌症研究与治疗组织 (RTOG/EORTC) 以及国家中心研究所不良事件通用术语标准第 5 版 (NCI- CTCAE）毒性评分系统。根据 RTOG/EORTC 和 NCI-CTCAE 评分系统，放射性皮炎从 RT 第三周开始出现≥2 级，两组均在第六周达到峰值。局部治疗患者的 2 级及以上急性皮炎发生率低于安慰剂组（51.3% vs. 66.7%），但这种差异没有统计学意义（相对风险 = 0.769，95% 置信区间，0.429–1.373） 。皮炎等级≥2级与体重指数≥30和年龄无关。在该组的六周随访期间，瘙痒更为常见。这项研究表明，7% 乳膏并没有显着降低急性放射性皮炎的严重程度。 建议未来的研究进行更大样本量的多中心试验并使用不同的外用制剂。 IRCT20150830023823N4。