Characterization of Treatment Responses in Lymphedema

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Characterization of Treatment Responses in Lymphedema

Conditions
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Lymphedema

Intervention / Treatment
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* Drug: Ketoprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with a history of acquired lymphedema Stage 1, 2, or 3 18-75 years Clinical use of ketoprofen for lymphedema Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ketoprofen<br>Participants will take ketoprofen for six months. They will have evaluations at baseline and month 6. | Drug: Ketoprofen<br>* Ketoprofen 200 mg ER, taken orally, once a day for 6 months. If medication, if obtained from a compound pharmacy, dose will be 210 mg ER, taken orally once a day for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF) | 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. | baseline and month 6. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Measurement of Skin Thickness | Caliper-measured skin thickness (mm) of upper or lower extremities, at 3 points, will be performed and recorded. Quantitative assessment of skin thickness (mm) of the affected limb at month 6 will be compared to baseline value. | baseline and month 6. | 
| Change in Limb Volume | Upper or lower limbs will be marked and measured at 4 cm intervals and circumferential measurements, with tape, will be performed and recorded. Quantitative assessment of limb volume (ml) of the affected limb at month 6 will be compared to baseline value. | baseline and month 6. |