Characterization of Treatment Responses in Lymphedema
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03783715|
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : June 28, 2021
|Condition or disease||Intervention/treatment|
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 :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Characterization of Treatment Responses in Lymphedema|
|Actual Study Start Date :||June 21, 2019|
|Estimated Primary Completion Date :||March 31, 2023|
|Estimated Study Completion Date :||August 31, 2023|
Participants will take ketoprofen for six months. They will have evaluations at baseline and month 6.
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.
- Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF) [ Time Frame: 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.
- Change in Measurement of Skin Thickness [ Time Frame: baseline and month 6. ]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.
- Change in Limb Volume [ Time Frame: baseline and month 6. ]
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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783715
|Contact: Leslie Roche, BSNfirstname.lastname@example.org|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Leslie Roche, RN 650-723-1396 email@example.com|
|Principal Investigator: Stanley G Rockson, MD|
|Principal Investigator:||Stanley G Rockson||Stanford University|