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临床试验/IRCT20180722040556N5
IRCT20180722040556N5招募中3 期

Evaluation of the effect of Melatonin in treatment of menopausal like problems, mood and sleep chaging caused by androgen deprivation therapy in prostate cancer patients

Esfahan University of Medical Sciences0 个研究点目标入组 66 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
66

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 no limit(—)
性别
Male

入选标准

  • All adult men (18 years and older) with prostate cancer treated with androgen deprivation therapy (ADT)
  • Patients with controlled hypertension
  • Patients who complain from menopausal complications such as hot flashes (at least 4 times a week in the past month)
  • Patient who has sufficient compliance and ability to take melatonin orally

排除标准

  • Patients in the metastatic stage of prostate cancer
  • Patients with a history of other malignancies except prostate cancer
  • Concomitant treatment with progesterone agents or other treatments related to hot flashes
  • Concomitant treatment with chemotherapy, radiotherapy or surgery in the future
  • Patients receiving drugs such as propranolol (due to the relative effect on the central nervous system) and warfarin (due to the high risk of drug interactions)
  • No history of liver and kidney disorder or advanced heart failure
  • Patients with a history of allergy to melatonin-containing products
  • Recent use of SSRIs, SNRIs, antiepileptic drugs, and monoamine oxidase inhibitors
  • Patients taking sedative drugs such as benzodiazepines or non-benzodiazepines (such as zolpidem) regularly due to sleep problems

研究者

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