- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03783715
Characterization of Treatment Responses in Lymphedema
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients presenting to the Investigator's Stanford Center for Lymphatic and Venous Disorders, for evaluation and treatment of their condition, lymphedema, will be assessed for their suitability for medical treatment with ketoprofen. The use of ketoprofen in these patients is predicated upon clinical presentation and evidence-based practice, not any investigational consideration of therapy.
If there are no contra-indications to taking ketoprofen, after discussion of FDA black box warnings, including provision of a written copy of the Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), approved by FDA, will be provided to the patient, and with the recommendation to discuss with the primary physician-of-record, patients will be provided with a prescription for ketoprofen. The opportunity to participate in this observational study will be presented.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Ketoprofen
Participants will take ketoprofen for six months.
They will have evaluations at baseline and month 6.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF)
Time Frame: baseline and month 6.
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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.
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baseline and month 6.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Measurement of Skin Thickness
Time Frame: baseline and month 6.
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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.
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baseline and month 6.
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Change in Limb Volume
Time Frame: baseline and month 6.
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stanley G Rockson, Stanford University
Publications and helpful links
General Publications
- Rockson SG, Tian W, Jiang X, Kuznetsova T, Haddad F, Zampell J, Mehrara B, Sampson JP, Roche L, Kim J, Nicolls MR. Pilot studies demonstrate the potential benefits of antiinflammatory therapy in human lymphedema. JCI Insight. 2018 Oct 18;3(20):e123775. doi: 10.1172/jci.insight.123775.
- Tian W, Rockson SG, Jiang X, Kim J, Begaye A, Shuffle EM, Tu AB, Cribb M, Nepiyushchikh Z, Feroze AH, Zamanian RT, Dhillon GS, Voelkel NF, Peters-Golden M, Kitajewski J, Dixon JB, Nicolls MR. Leukotriene B4 antagonism ameliorates experimental lymphedema. Sci Transl Med. 2017 May 10;9(389):eaal3920. doi: 10.1126/scitranslmed.aal3920.
- Nakamura K, Radhakrishnan K, Wong YM, Rockson SG. Anti-inflammatory pharmacotherapy with ketoprofen ameliorates experimental lymphatic vascular insufficiency in mice. PLoS One. 2009 Dec 21;4(12):e8380. doi: 10.1371/journal.pone.0008380.
- Tabibiazar R, Cheung L, Han J, Swanson J, Beilhack A, An A, Dadras SS, Rockson N, Joshi S, Wagner R, Rockson SG. Inflammatory manifestations of experimental lymphatic insufficiency. PLoS Med. 2006 Jul;3(7):e254. doi: 10.1371/journal.pmed.0030254.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Lymphatic Diseases
- Lymphedema
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ketoprofen
Other Study ID Numbers
- 49078
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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