School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Urology and Nephrology Research Center, Student Research Committee, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Phytother Res. 2019 Feb;33(2):370-378. doi: 10.1002/ptr.6230. Epub 2018 Nov 14.
Clinical potential of curcumin in radiotherapy (RT) setting is outstanding and of high interest. The main purpose of this randomized controlled trial (RCT) was to assess the beneficial role of nanocurcumin to prevent and/or mitigate radiation-induced proctitis in prostate cancer patients undergoing RT. In this parallel-group study, 64 eligible patients with prostate cancer were randomized to receive either oral nanocurcumin (120 mg/day) or placebo 3 days before and during the RT course. Acute toxicities including proctitis and cystitis were assessed weekly during the treatment and once thereafter using CTCAE v.4.03 grading criteria. Baseline-adjusted hematologic nadirs were also analyzed and compared between the two groups. The patients undergoing definitive RT were followed to evaluate the tumor response. Nanocurcumin was well tolerated. Radiation-induced proctitis was noted in 18/31 (58.1%) of the placebo-treated patients versus 15/33 (45.5%) of nanocurcumin-treated patients (p = 0.313). No significant difference was also found between the two groups with regard to radiation-induced cystitis, duration of radiation toxicities, hematologic nadirs, and tumor response. In conclusion, this RCT was underpowered to indicate the efficacy of nanocurcumin in this clinical setting but could provide a considerable new translational insight to bridge the gap between the laboratory and clinical practice.
姜黄素在放射治疗（RT）中的临床潜力是突出的，具有很高的研究兴趣。本随机对照试验（RCT）的主要目的是评估纳米姜黄素在预防和/或减轻接受 RT 的前列腺癌患者放射性直肠炎中的有益作用。在这项平行组研究中，64 名符合条件的前列腺癌患者被随机分为两组，分别接受口服纳米姜黄素（120mg/天）或安慰剂，在 RT 疗程前 3 天和期间服用。在治疗期间每周评估急性毒性，包括直肠炎和膀胱炎，并在治疗后使用 CTCAE v.4.03 分级标准进行一次评估。还分析了两组之间的基线调整后的血液学最低点，并进行了比较。对接受根治性 RT 的患者进行随访，以评估肿瘤反应。纳米姜黄素具有良好的耐受性。在接受安慰剂治疗的 31 名患者中，有 18 名（58.1%）出现放射性直肠炎，而接受纳米姜黄素治疗的 33 名患者中，有 15 名（45.5%）出现放射性直肠炎（p=0.313）。两组在放射性膀胱炎、毒性持续时间、血液学最低点和肿瘤反应方面也没有显著差异。总之，本 RCT 没有足够的效力来表明纳米姜黄素在这种临床环境中的疗效，但可以为缩小实验室和临床实践之间的差距提供重要的新转化见解。
