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首页> 外文期刊>Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer >Novel hyaluronan formulation for preventing acute skin reactions in breast during radiotherapy: a randomized clinical trial
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Novel hyaluronan formulation for preventing acute skin reactions in breast during radiotherapy: a randomized clinical trial

机译：用于防止放疗期间乳腺癌中急性皮肤反应的新型透明质酸锰酸：随机临床试验

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Purpose We conducted a randomized, double-blind, vehicle-controlled clinical trial to investigate the use of a new proprietary hyaluronan (HA) formulation for the prevention of acute skin toxicity in breast cancer patients undergoing radiotherapy (RT). Methods Thirty women with breast cancer undergoing whole breast RT were enrolled. Each patient was randomly assigned to HA formulation (study cream, S) on the medial or lateral half of the irradiated breast and the control cream (placebo, P) on the other half. The primary endpoint was physician's evaluation of skin symptoms at week 5 during RT and week 2 post-RT. We also collected patients' independent assessment of skin after RT, patient's product preference, and an independent physician panel assessment of skin reactions based on photographs. Results Twenty-eight patients were evaluable. On physician's evaluation, there was no significant difference in radiation dermatitis between S and P and no overall preference to either cream at week 5 during or week 2 post-RT. More patients preferred S in evaluating skin appearance and skin reactions, but this did not reach statistical significance. Univariate analysis showed that physicians had an overall preference to the S cream at week 2 post-RT in patients with larger breasts. On the independent panel assessment, 3 reviewers saw no significant difference in radiation toxicity, whereas one reviewer reported better skin outcome with S cream at week 5. Conclusions We found a nonstatistically significant patient preference but overall no significant radioprotective effects for this HA formulation compared with placebo except in patients with larger breasts.
机译：目的，我们进行了随机，双盲，车辆控制的临床试验，以研究使用新的透明质酸（HA）制剂用于预防放疗乳腺癌患者（RT）的乳腺癌患者的急性皮肤毒性。方法注册了接受全乳腺炎全乳腺癌的30间女性。将每位患者随机分配到辐照乳房和对照乳膏（安慰剂，P）的内侧或外侧一半的内侧或外侧一半的HA配方（研究霜，S）。主要终点是医生在第5周的RT和第2周后第5周对皮肤症状的评估。我们还在RT，患者的产品偏好和基于照片的皮肤反应的独立医生面板评估的患者对皮肤的独立评估。结果28名患者是评估的。在医生的评价上，S和P之间的辐射性皮炎没有显着差异，并且在第5周或第2周的第5周内没有整体偏好于任何一种乳霜。更多患者优先考虑皮肤外观和皮肤反应，但这并未达到统计学意义。单变量分析表明，医生在较大的乳房患者的第2周的第2周后对S奶油的总体偏好。在独立面板评估中，3名审查员对辐射毒性没有显着差异，而一周审查员在第5周报告了S奶油的更好的皮肤结果5.我们发现与此类HA配方无明显显着的放射性反应效应除乳房较大的患者外。

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