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临床试验/EUCTR2018-003416-50-DK
EUCTR2018-003416-50-DK进行中(未招募)1 期

Prevention of breast cancer-related lymphedema with tacrolimus

Odense University Hospital0 个研究点目标入组 40 人开始时间: 2018年10月3日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Diagnosticeret med brystkræft og skal have fjernet samtlige lymfeknuder i armhulen ved operation, som led i kræftbehandlingen.
  • Indikationen for fjernelse af alle lymfeknuder i armhulen.
  • Alder mellem 18-75 år
  • Postmopausal (udebleven menstruation i min. 12 mdr.) eller kontinuerligt brug af svangerskabsforebyggende midler (Spiral, p-piller, implantat, transdermal depotplastre, vaginalring eller depotinjektion)
  • God almentilstand (ASA score 1 eller 2)
  • Modsatte arm er normal (intet lymfødem)
  • Forstår undersøgelsens formål og natur og giver skriftligt informeret samtykke.
  • Kan læse og forstå dansk.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • Pregnant, breastfeeding or wishing to conceive within the next year.
  • Bilateral breast cancer
  • Known allergy to Tacrolimus or the macrolide type antibiotics.
  • Removal of lymph nodes from the opposite armpit.
  • Known lymphedema in parallel or opposite arm
  • Other malignant disease in addition to breast cancer (non-melanoma skin cancer)
  • In medical treatment for diabetes mellitus.
  • Known with psychiatric disorder that may influence participation in the study.
  • Known with poor renal or hepatic function.

研究者

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