Lozanovski Vladimir J, Houben Philipp, Hinz Ulf, Hackert Thilo, Herr Ingrid, Schemmer Peter
Department of General and Transplant Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.
Trials. 2014 Jun 3;15:204. doi: 10.1186/1745-6215-15-204.
Pancreatic ductal adenocarcinoma (PDA) is one of the most aggressive malignancies with marked resistance to chemo- and radiotherapy. PDA-cancer stem cells (CSCs) are not targeted by current therapies and may be a reason for poor prognosis. Studies indicate that diets rich in cabbage, broccoli, and cauliflower offer cancer preventative and therapeutic benefits. Recent experimental studies have confirmed these findings and demonstrated that isothiocyanate, sulforaphane, and the polyphenol, quercetin, effectively reduced tumor growth and enhanced the sensitivity of the cancer cells to current chemotherapeutics. The aim of the present study is to test the feasibility of a randomized controlled trial on the application of freeze-dried broccoli sprouts in patients with advanced PDA.
The study is designed as a prospective randomized, double-blinded pilot trial with a treatment and a placebo-controlled arm in a single center setting. A total number of forty patients (18 years or older) in two parallel groups with advanced, surgically non-resectable PDA under palliative chemotherapy are planned for recruitment. Patients in the treatment group will receive fifteen capsules of the study substance per day (90 mg of active sulforaphane) during the chemotherapy treatment course. Patients in the placebo group will receive the same capsule size and portion distribution with inactive substances (mainly methylcellulose). The follow-up duration is one year. Feasibility of the study substance, adverse effects, and patient compliance, as well as levels of serum tumor markers (CEA, CA 19-9), quality of life, and patient overall survival rates will be assessed at defined points of time.
The POUDER trial is expected to transfer promising experimental and epidemiological data into a clinical pilot study to assess the effectiveness of broccoli sprout extracts in the treatment of advanced PDA. The study objectives will provide data on the clinical feasibility and acceptability of a supportive treatment option accompanying palliative chemotherapy. Based on these results, future clinical studies to create further evidence in this field are possible.
The POUDER trial has been registered at ClinicalTrials.gov with an ID NCT01879878 and WHO with an ID U1111-1144-2013 on June 13th 2013.
胰腺导管腺癌（PDA）是侵袭性最强的恶性肿瘤之一，对化疗和放疗具有显著抗性。PDA癌症干细胞（CSCs）不受当前疗法的靶向作用，可能是预后不良的一个原因。研究表明，富含卷心菜、西兰花和花椰菜的饮食具有防癌和治疗功效。最近的实验研究证实了这些发现，并表明异硫氰酸酯、萝卜硫素和多酚槲皮素能有效抑制肿瘤生长，并增强癌细胞对当前化疗药物的敏感性。本研究的目的是测试在晚期PDA患者中应用冻干西兰花芽进行随机对照试验的可行性。
本研究设计为一项前瞻性随机双盲试点试验，在单一中心环境下设立治疗组和安慰剂对照组。计划招募总共40名（18岁及以上）处于姑息化疗阶段、患有晚期、手术不可切除PDA的平行组患者。治疗组患者在化疗疗程期间每天将服用15粒研究物质胶囊（90毫克活性萝卜硫素）。安慰剂组患者将接受相同胶囊大小和份量分布的无活性物质（主要是甲基纤维素）。随访期为一年。将在规定时间点评估研究物质的可行性、不良反应、患者依从性，以及血清肿瘤标志物（癌胚抗原、CA 19-9）水平、生活质量和患者总生存率。
POUDER试验有望将有前景的实验和流行病学数据转化为临床试点研究，以评估西兰花芽提取物在治疗晚期PDA中的有效性。研究目标将提供关于姑息化疗辅助支持性治疗方案的临床可行性和可接受性的数据。基于这些结果，未来有可能在该领域开展进一步提供证据的临床研究。
POUDER试验已于2013年6月13日在ClinicalTrials.gov注册，注册号为NCT01879878，在世界卫生组织注册，注册号为U1111-1144-2013。
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