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临床试验/NCT02017353
NCT02017353已完成2 期

Effect of Curcumin Addition to Standard Treatment on Tumour-induced Inflammation in Endometrial Carcinoma

University Hospital, Gasthuisberg2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年10月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
7
试验地点
2
主要终点
Change in inflammatory markers in peripheral blood from baseline

研究概览

简要总结

This therapy aims to determine whether curcumin can inhibit tumor induced inflammation in patients with endometrial carcinoma. In addition, curcumin could possibly induce a better functioning of chemotherapy and a decrease in toxicity from chemotherapy. Various studies have demonstrated that curcumin can have an effect on tumor growth and the development of metastases.

详细描述

Various cancer types are associated with chronic inflammation. During the formation of cancer the immune system is being activated by the tumor in order to evoke an anti-tumor immune response. However, as the tumor develops, this gives rise to a chronic inflammation, causing the immune system to malfunction. This is being highlighted by the fact that different chronic inflammatory diseases are associated with an increased risk of cancer (f.i. chronic inflammatory bowel diseases and colon cancer, prostatitis and prostate cancer, hepatitis and liver cancer). Endometrial cancer reveals different aspects of inflammation, including cytokine secretion and the infiltration of immune cells in this type of tumors. It is presumed that hormonal fluctuations and genetic changes contribute to the formation of a pro-inflammatory environment that stimulates tumor growth. Cancer cells of endometrial tumors do not only produce immunomodulatory mediators, but also attract different sorts of cells of the immune system that stimulate tumor growth.

It has already been demonstrated in mice models and in vitro experiments that curcumin shows strong anti-inflammatory effects that can slow down tumor growth and/or prevent formation of metastases. In addition, it has been noticed in these models that curcumin also has a positive effect on the functioning of various chemotherapeutic drugs, causing their effect to enhance or their toxicity to decrease.

Clinical studies investigating the anti-inflammatory effect of curcumin are rare, but these studies do reveal a suppression of the inflammation. The primary reason why clinical studies with curcumin are rare is because of the bad intake of curcumin in the human body. Recently, there has been a lot of research carried out regarding the development of new formulations of curcumin that lead to a better intake in the human body. The best nutritional supplement containing curcumin that has been developed so far is Meriva®, which is commercialized in Belgium under the name "CurcuPhyt".

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Endometrial carcinoma at time of recurrence
  • No life-threatening metastases

排除标准

  • Other active malignancy
  • Documented autoimmune disease
  • Currently ongoing immunosuppressive therapy
  • Simultaneous treatment according to other clinical trials
  • Documented immune deficiency

结局指标

主要结局

Change in inflammatory markers in peripheral blood from baseline

时间窗: baseline, day 1, day 7, day 14, day 21

次要结局

  • Number of Participants with Serious and Non-Serious Adverse Events(up to 3 weeks)
  • Change from Baseline in Quality of Life score(baseline, day 14)

研究者

发起方
University Hospital, Gasthuisberg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Tuyaerts

PhD

University Hospital, Gasthuisberg

研究点 (2)

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