NCT06306274Enrolling By Invitation2 期
Topical Tacrolimus for the Amelioration of Breast Cancer-related Lymphedema: a Randomized, Double-blind, Placebo-controlled Phase II/III Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Lymphedema volume
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are:
- How tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life).
- If maintenance treatment is effective. Participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. Assessments will be performed at baseline, three, six, nine and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age over 18 years
- •BCRL ISL stage I or II
- •Pitting edema
- •Postmenopausal or use of Contraceptive drugs
- •Healthy opposite arm
- •L-Dex score over 10
排除标准
- •Pregnant, breast-feeding, or aiming to conceive within the next year
- •Bilateral breast cancer
- •Contralateral lymphadenectomy
- •Allergy to tacrolimus, macrolides, or iodine
- •Pacemaker
- •Known kidney or liver disease
研究组 & 干预措施
Active
Experimental
干预措施: Tacrolimus (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Lymphedema volume
时间窗: Baseline to 12 months
Change in lymphedema volume (volume of lymphedema arm - volume of healty arm)
次要结局
未报告次要终点
研究者
研究点 (3)
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