Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Stanley Rockson, Stanford University

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.

Condition or disease Intervention/treatment
Lymphedema Drug: Ketoprofen

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Treatment Responses in Lymphedema
Actual Study Start Date : June 21, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema
Drug Information available for: Ketoprofen

Group/Cohort Intervention/treatment
Ketoprofen
Participants will take ketoprofen for six months. They will have evaluations at baseline and month 6.
Drug: Ketoprofen
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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
Plasma samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Leslie Roche, BSN 650-723-1396 lesroche@stanford.edu

Locations
Layout table for location information
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Leslie Roche, RN    650-723-1396    lesroche@stanford.edu   
Principal Investigator: Stanley G Rockson, MD         
Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Stanley G Rockson Stanford University

Publications:
Layout table for additonal information
Responsible Party: Stanley Rockson, Allan and Tina Neill Professor of Lymphatic Research and Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03783715     History of Changes
Other Study ID Numbers: 49078
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant data, for study endpoints, will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will become available 12 months after completion of the last enrollment in the trial.
Access Criteria: Data access requests will be reviewed by PI and Stanford IRB. If approved, requestors will be required to sign a data use agreement (DUA).

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphedema
Lymphatic Diseases
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action