Characterization of Treatment Responses in Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF)
研究概览
简要总结
This study is designed to investigate the treatment response of lymphedema, of the upper or lower extremity, during clinical, pharmacologic treatment of lymphedema with oral ketoprofen. Correlation of clinical responses (changes in limb volume and skin thickness) with changes in the inflammasome will help to define the molecular substrate of treatment response.
详细描述
Patients presenting to the Investigator's Clinic for evaluation and treatment of (upper or lower extremity) lymphedema, will be assessed for their suitability (of low risk) for medical treatment with ketoprofen. If there are no contra-indications to taking ketoprofen, after discussion of FDA warnings, including provision of a written copy of the FDA language to the patient, and with the recommendation to discuss with the primary physician-of-record, patients will be provided with a prescription for ketoprofen 200 mg daily (one capsule taken orally, once daily) or if obtained from a compound pharmacy, ketoprofen 210 mg daily (one capsule taken orally, once daily).
Participation in this study will be offered. Two study visits, at baseline and month 6 are required. Measurements (circumferential and skin thickness) and a blood sample will be taken at each study visit.
The investigators will try to determine how ketoprofen affects the body tissue by obtaining blood samples and measurements, before starting treatment and at month 6.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a history of acquired lymphedema
- •Stage 1, 2, or 3
- •18-75 years
- •Clinical use of ketoprofen for lymphedema
排除标准
- •Active cancer, infection, bleeding tendency, inflammatory disease and/or taking anti-inflammatory or anti-leukotriene medication will be excluded.
- •Pregnant or lactating females
- •Inability to take ketoprofen (contra-indicated, e.g patients with known CV, GI, renal, hepatic disease).
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, may interfere with interpretation of study results, and in the judgement of the investigator, would make the participation inappropriate for entry into this study.
研究组 & 干预措施
Ketoprofen
Participants will take ketoprofen for six months. They will have evaluations at baseline and month 6.
干预措施: Ketoprofen (Drug)
结局指标
主要结局
Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF)
时间窗: baseline and month 6.
The systemic inflammatory response of G-CSF, in patients treated with Ketoprofen will be assessed with Luminex-bead inflammasome analysis at baseline and 6 months post-treatment plasma samples. G-CSF, a glycoprotein, is an inflammatory cytokine produced by endothelium and immune cells. Ketoprofen is a unique NSAID possessing dual pathways of inflammatory inhibition, blocking cyclooxygenase (COX) and arachidonate 5-lipoxygenase (5-LO). Measurement using median fluorescence intensity (MFI) will be employed.
次要结局
- Change in Measurement of Skin Thickness(baseline and month 6.)
- Change in Limb Volume(baseline and month 6.)
研究者
Stanley Rockson
Allan and Tina Neill Professor of Lymphatic Research and Medicine
Stanford University