NCT04390685Unknown1 期
Prevention of Breast Cancer-related Lymphedma With Tacrolimus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Lymphedema
研究概览
简要总结
Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Tacrolimus ointment may prevent lymphedema by inhibition of CD4+T cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer with planned ALND
- •postmenopausal or use of contraceptives
- •good general health condition
- •read and understand Danish
排除标准
- •Pregnant, breastfeeding it wishing to conceive with the next year
- •bilateral breast cancer
- •known allergy to tacrolimus or macrolides
- •known lymphedema
- •other malignant disease apart from keratinocyte cancer
- •in medical treatment for diabetes mellitus
- •known psychiatric condition which may influence participation
- •known renal or hepatic function
研究组 & 干预措施
Tacrolimus ointment
Experimental
Apply whole arm, in a thin layer, once daily for one year
干预措施: Tacrolimus ointment (Drug)
结局指标
主要结局
Lymphedema
时间窗: 1 year
Arm size change \>= 10% using water displacement
次要结局
- Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire(1 year)
- Change in lymph drainage. (Odense University Hospital Only).(1 year)
- Change in L-DEX score using bioimpedance (Odense University Hospital Only).(1 year)
- Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire(1 year)
- Subjective changes assessed using SF-36 questionnaire (Short form-36)(1 year)
研究者
Mads Gustaf Jørgensen
Medical doctor, ph.d.-student.
Odense University Hospital
研究点 (3)
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