本双盲、安慰剂对照、随机试验旨在研究外用褪黑素能否在放疗期间增加原发性乳腺癌患者的生命质量。患者从第一次辐射治疗开始，到最后一次治疗后3周进行随访。患者每天两次将1克包含25毫克/克褪黑素和150毫克/克二甲基磺酰氧化物的霜剂涂于皮肤放疗区域，并用安慰剂霜剂进行对照。结果是在最后一天辐射治疗时使用欧洲癌症研究组织乳腺癌生命质量问卷（QLQ-C30和QLQ-BR23）评估生命质量。作为次要结局，我们在重复测量线性模型中评估了整个试验期间的乳腺症状（BS）评分。我们纳入了65名患者，并有17名退出，因此总计褪黑素组和安慰剂组分别为26名和22名患者。辐射治疗的最后一天BS评分在两组之间没有差异（p = 0.333）。然而，线性模型分析整个过程中的BS评分显示褪黑素显著降低了症状（p = 0.001）。在放疗的最后一天BS评分没有差异，但我们发现褪黑素组的患者在整个试验期间乳腺症状评分显著降低。© 2022 The Authors. Journal of Pineal Research published by John Wiley & Sons Ltd.

The aim of this double-blind, placebo-controlled, randomized study was to investigate whether topical melatonin administered during radiation therapy could increase the quality of life in patients with primary breast cancer. Patients were followed from the first radiation fraction until 3 weeks after the last. The patients applied 1 g of cream to the irradiated area of the skin twice daily, consisting of either 25 mg/g melatonin and 150 mg/g dimethyl sulfoxide, or a placebo cream. Outcomes were the European Organisation for Research and Treatment of Cancer's quality-of-life questionnaires for breast cancer (QLQ-C30 and QLQ-BR23) on the last day of radiation therapy. As a secondary outcome, we evaluated the breast symptom (BS) scores over the entire duration of the trial in a repeated measures linear model. We included 65 patients and had 17 drop-outs, thus totaling 26 and 22 patients in the melatonin and placebo groups, respectively. BS scores on the last day of radiation did not differ between groups (p = .333). However, the linear model analyzing BS for the entire duration showed that melatonin significantly decreased the symptoms (p = .001). There was no difference in the BS score on the last day of radiation, however, we found that the patients in the melatonin group had significantly lower BS scores over the entire duration of the trial.© 2022 The Authors. Journal of Pineal Research published by John Wiley & Sons Ltd.