Characterization of Treatment Responses in Lymphedema

Stanford University

Status: Terminated

Conditions: Lymphedema

Treatments: Drug: Ketoprofen

Study type: Observational

Funder types: Other

Identifiers

NCT03783715

49078

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2 participants in 1 patient group

Ketoprofen

Description:

Participants will take ketoprofen for six months. They will have evaluations at baseline and month 6.

Treatment:

Drug: Ketoprofen