皮肤恶性黑色素瘤结局中维生素D补充剂（ViDMe）：一项随机对照试验。
Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial.
作者信息
De Smedt J, Van Kelst S, Boecxstaens V, Stas M, Bogaerts K, Vanderschueren D, Aura C, Vandenberghe K, Lambrechts D, Wolter P, Bechter O, Nikkels A, Strobbe T, Emri G, Marasigan V, Garmyn M
机构信息
Laboratory of Dermatology, Department of oncology, KU Leuven, 3000, Leuven, Belgium.
Department of Dermatology, University Hospitals Leuven, 3000, Leuven, Belgium.
出版信息
BMC Cancer. 2017 Aug 23;17(1):562. doi: 10.1186/s12885-017-3538-4.
BACKGROUND
Previous studies have investigated the protective effect of vitamin D serum levels, at diagnosis and during the follow-up period after treatment, on melanoma outcome. In the present study we assess whether vitamin D supplementation, in the follow-up period after diagnosis and surgical resection of the primary tumor, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and Vitamin D Receptor immunoreactivity in the primary tumor.
METHODS/DESIGN: This study is a multicenter randomized double blind placebo- controlled phase III trial. Patients between the age of 18 and 80 years diagnosed and treated surgically for a melanoma stage IB-III are eligible for randomization in a 1:1 ratio to active treatment or placebo. The study drug is taken each month and consists of either 100,000 International Unit cholecalciferol or arachidis oleum raffinatum used as a placebo. The primary endpoint is relapse free survival. The secondary endpoints are 25 hydroxyvitamin D3 serum levels at diagnosis and at 6 month intervals, melanoma subtype, melanoma site and stage of melanoma at diagnosis according to the 2009 American Joint Committee on Cancer melanoma staging and classification. At randomization a bloodsample is taken for DNA analysis. The study is approved by the local Ethics Committees.
DISCUSSION
If we can confirm our hypothesis that vitamin D supplementation after removal of the tumor has a protective effect on relapse of cutaneous malignant melanoma we may reduce the burden of CMM at several levels. Patients, diagnosed with melanoma may have a better clinical outcome and improved quality of life. There will be a decrease in health care costs related to treatment of metastatic disease and there will be a decrease in loss of professional years, which will markedly reduce the economic burden of the disease.
TRIAL REGISTRATION
Clinical Trial.gov, NCT01748448 , 05/12/2012.
背景
既往研究探讨了维生素D血清水平在黑色素瘤诊断时及治疗后随访期间对其预后的保护作用。在本研究中，我们评估在原发性肿瘤诊断及手术切除后的随访期补充维生素D，是否对皮肤恶性黑色素瘤复发具有保护作用，以及这种保护作用是否与血清维生素D水平和原发性肿瘤中维生素D受体免疫反应性相关。
方法/设计：本研究是一项多中心随机双盲安慰剂对照III期试验。年龄在18至80岁之间、经手术诊断和治疗的IB - III期黑色素瘤患者，有资格按1:1比例随机分为接受活性治疗或安慰剂治疗。研究药物每月服用一次，由100,000国际单位胆钙化醇或精制花生油（用作安慰剂）组成。主要终点是无复发生存期。次要终点是诊断时及每隔6个月的25羟维生素D3血清水平、黑色素瘤亚型、黑色素瘤部位以及根据2009年美国癌症联合委员会黑色素瘤分期和分类标准在诊断时的黑色素瘤分期。随机分组时采集血样进行DNA分析。本研究已获得当地伦理委员会批准。
讨论
如果我们能够证实我们的假设，即肿瘤切除后补充维生素D对皮肤恶性黑色素瘤复发具有保护作用，我们可能会在多个层面减轻皮肤恶性黑色素瘤的负担。被诊断为黑色素瘤的患者可能会有更好的临床结局和更高的生活质量。与转移性疾病治疗相关的医疗费用将会降低，职业年限的损失也会减少，这将显著减轻该疾病的经济负担。
试验注册
Clinical Trial.gov，NCT01748448，2012年12月5日。
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