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临床试验/NCT03959618
NCT03959618已完成不适用

Mono-centric, Prospective, Non-Interventional Study of Quantitative and Qualitative Analysis of Dietary Supplement Taken With Chemotherapy Treatments in Patients With Adjuvant Breast Cancer Taken Care of at the Day Hospital

Institut Cancerologie de l'Ouest1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
evaluate quantitatively the use of dietary supplements in patients during IV chemotherapy

研究概览

简要总结

More and more patients report taking dietary supplements based on herbal medicine, aromatherapy, vitamintherapy,... in the course of their detoxifying anticancer chemotherapy, to stimulate the immune defenses, to relieve and/or decrease the side effects of chemo or even to act against cancer. At European level, there are between 15 and 73% of patients treated for cancer taking a dietary supplement (in particular phytotherapy) or a great heterogeneity according to the studies. However, there is still little evidence of the efficacy of these dietary supplements. A large proportion of patients do not seem to inform their doctor about the use of dietary supplements. Patients using dietary supplements most often ignore the mode of action of these products and generally say they are not informed.

In 2015, at the West Cancerology Institute (ICO), 5 patient files were analyzed taking this type of treatment in addition to chemotherapy; in 2016, 24 files; 2017, 61 patient records and this continues to progress.

At the same time, a product appears very frequently associated with cancer chemotherapy: Desmodium Adscendens, an African plant with in vitro properties of liver protector. The Desmodium contains triterpene saponins, alkaloids, flavonoids, polyphenols, and tryptamine derivatives.

Morevover, several situations of patients undergoing chemotherapy and taking long-term Desmodium, with hepatic cytolyses were experienced, not explained by the usual treatments (case described in the literature).

Therefore, this study will evaluate these new therapeutic modalities that are included in the intake of chemotherapy in order to better know them to improve the therapeutic taking of patients and to focus on the impact of Desmodium in association with chemotherapy.

详细描述

  • Determine the quantitative impact of the use of dietary supplements by patients with breast cancer and treated in a neo-adjuvant and/or adjuvant condition by IV chemotherapy in day hospital.
  • Determine an over-risk of disruption of liver balance in the population of patients taking Desmodium.
  • Gather a critical mass of relevant information with the objective of carrying out the evaluation and analysis of cancer care practices related to the intake of dietary supplements.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • breast cancer treated by intra-venous chemotherapy
  • inclusion at the last cycle (cure)
  • all chemotherapy cycles realised at ICO

排除标准

  • no breast cancer
  • metastatic breast cancer
  • not all chemotherapy cycles realised at ICO
  • patient who has not finished his chemotherapy

结局指标

主要结局

evaluate quantitatively the use of dietary supplements in patients during IV chemotherapy

时间窗: 12 months

rate of patients taking a dietary supplement

次要结局

  • Description of dietary supplements taken(12 months)
  • Evaluate the impact of taking Desmodium between the first and last cycle of treatment(12 months)

研究者

发起方
Institut Cancerologie de l'Ouest
申办方类型
Other
责任方
Sponsor

研究点 (1)

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