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Characterization of Treatment Responses in Lymphedema

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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

Tracking Information
First Submitted Date December 19, 2018
First Posted Date December 21, 2018
Last Update Posted Date August 26, 2019
Actual Study Start Date June 21, 2019
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2018)
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.
Original Primary Outcome Measures
 (submitted: December 19, 2018)
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 5-LO. Measurement using median fluorescence intensity (MFI) will be employed.
Change History Complete list of historical versions of study NCT03783715 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 19, 2018)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterization of Treatment Responses in Lymphedema
Official Title Characterization of Treatment Responses in Lymphedema
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma samples
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.

Condition Lymphedema
Intervention 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.
Study Groups/Cohorts Ketoprofen
Participants will take ketoprofen for six months. They will have evaluations at baseline and month 6.
Intervention: Drug: Ketoprofen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 19, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Leslie Roche, BSN 650-723-1396 lesroche@stanford.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03783715
Other Study ID Numbers 49078
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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).
Responsible Party Stanley Rockson, Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Stanley G Rockson Stanford University
PRS Account Stanford University
Verification Date August 2019