Clinical trial NCT03783715: Characterization of Treatment Responses in Lymphedema
Official title: Characterization of Treatment Responses in Lymphedema
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lymphedema
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF)
timeFrame: baseline and month 6.
Secondary outcomes:
measure: Change in Measurement of Skin Thickness
timeFrame: baseline and month 6.
measure: Change in Limb Volume
timeFrame: baseline and month 6.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Stanley G Rockson
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.