Pilot Study to Test Uniformity of Transdermal Drug Delivery to the Breast Using Diclofenac Epolamine as a Model
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Compare concentrations of diclofenac epolamine patch when applied to breast vs. abdomen
研究概览
简要总结
The purpose of this study is to look for ways to improve breast cancer treatment by giving breast cancer drugs through the skin of the breast.
The drug used in this study is a diclofenac epolamine patch and is a nonsteroid anti-inflammatory pain reliever. The drug amount that gathers in the breast, after application of a patch to the skin of the breast, will be measured and compared to the amount that is found in the breast when the patch is applied to the skin of the belly.
详细描述
This is a randomized study where participants in group 1 will apply the diclofenac epolamine patch to the breast and participants in group 2 will apply the same drug to her abdomen. Participants are instructed to apply a new patch every 12 hours for 3 days. Total participation in this study will be for three days, ending on the day of surgery. On the day of surgery, participants will have blood drawn to measure the level of diclofenac epolamine in the body, and the final patch will be removed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 18 and 80 years, undergoing total mastectomy for, with or without axillary surgery for diagnosis or prevention of breast cancer.
- •ECOG performance status less than
- •Ability to understand and the willingness to sign a written informed consent.
- •Participants must have normal organ and marrow function
排除标准
- •Prior history of ipsilateral breast radiotherapy.
- •Pregnant women and those who will be actively breast-feeding in the preoperative period will be excluded.
- •Inability to discontinue aspirin or warfarin use during the period of participation.
- •Known allergy to diclofenac epolamine, or aspirin, diclofenac (Cataflam, Voltaren), or another non-steroidal anti-inflammatory drug (NSAID).
- •Renal failure
研究组 & 干预措施
Breast Group
Diclofenac epolamine patch applied to the breast
干预措施: Diclofenac epolamine patch (Drug)
Abdomen Group
Diclofenac epolamine patch applied to the abdomen
干预措施: Diclofenac epolamine patch (Drug)
结局指标
主要结局
Compare concentrations of diclofenac epolamine patch when applied to breast vs. abdomen
时间窗: after 3 days of treatment prior to surgery
The primary objective of this protocol will demonstrate that diclofenac epolamine patch applied to the skin of the breast for three days (1, 2) prior to surgery will result in significantly higher drug concentrations in the breast than the same dose applied to the abdominal skin for the same duration of time.
次要结局
- Determine how the concentrations of the study patch is distributed in the breast.(after three days of treatment prior to surgery)