Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema in High Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of Participants With Incidence of Lymphedema
研究概览
简要总结
This randomized clinical trial studies an investigational drug in preventing lymphedema in patients at high risk after undergoing axillary lymph node dissection. The study drug may prevent lymphedema in patients undergoing axillary lymph node dissection.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of study drug in improving chronic lymphedema while further elucidating the role of inflammatory and lymphangiogenic processes in the pathogenesis of this disease.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive study drug orally (PO) thrice daily (TID) for up to 1 year in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Axillary lymph node dissection within the preceding 12 months
排除标准
- •Patients with active cancer
- •Patients with lymphedema
- •Infection or bleeding tendency
- •Patients with medical contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including history of allergies, know gastrointestinal intolerance
- •Other serious systemic illness (e.g., renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would impair the patients' ability to participate
- •Persons not competent to consent
- •Patients on aspirin therapy
- •Minors (< 18 years of age)
- •Pregnant and/or lactating women
研究组 & 干预措施
(RS)2-(3-benzoylphenyl)-propionic acid
Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed.
干预措施: (RS)2-(3-benzoylphenyl)-propionic acid (Drug)
(RS)2-(3-benzoylphenyl)-propionic acid
Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed.
干预措施: laboratory biomarker analysis (Other)
placebo for study drug
Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed.
干预措施: placebo for study drug (Drug)
placebo for study drug
Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Number of Participants With Incidence of Lymphedema
时间窗: Up to 1 year
Participants were evaluated every 3 months up to one year post lymph node dissection
次要结局
未报告次要终点
研究者
Stanley Rockson
Allan and Tina Neill Professor of Lymphatic Research and Medicine
Stanford University