Lymphedema Study for Arm or Leg Lymphedema

Lymphedema Clinical Trial

Official title:

Placebo-controlled, Case-controlled, Open Label Therapeutic Trial for Unilateral or Bilateral Lymphedema of Arm or Leg.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02257970
• Other study ID #: 7781
• Status: Completed
• Phase: Phase 4
• Start date: March 2009
• Est. completion date: March 2017

Study information

• Verified date: October 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares the effectiveness of a study drug versus placebo in the treatment of lymphedema.

Description:

Part 1 is feasibility, exploratory, open-label study of ketoprofen, to document effects.

Part 2, is open-label trial of ketoprofen to document histological response. Part 3 is double-blind randomized trial of receive placebo or ketoprofen to evaluate safety and efficacy.

We will try to determine how the study drug affects the body tissue by obtaining tissue biopsies (small pieces of skin from the arm or leg) before treatment and after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• a history of lymphedema of one or more limbs (unilateral or bilateral), with a duration of > 6 months.

Exclusion Criteria:

• Patients with active cancer, infection or bleeding tendency will be excluded.

• We will also exclude patients with medical contraindications to NSAIDs, including history of allergies, know gastrointestinal intolerance, or other serious systemic illness (e.g., renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would impair the patients' ability to participate.

• Minors (<18 years of age) *>90 years of age

Related Conditions & MeSH terms

• Lymphedema

Intervention

Drug:
• Ketoprofen

• Placebo
Placebo to match ketoprofen.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Count of Participants Able to Complete Ketoprofen Treatment	Participants who were able to complete ketoprofen treatment and experienced no treatment-related serious adverse events.	Baseline to month 6
Primary	Part 2: Change From Baseline in Cutaneous Histological Architecture	Quantitative assessment of paired histological specimens of lymphedema skin pre- and post-treatment with ketoprofen. The impact of treatment on cutaneous histopathology was evaluated through the use of an empirically-derived scoring system (comprised of dermal thickness, intercellular mucin content, deep dermal collagen content, and perivascular infiltrate); this quantitative assessment was developed and performed by a dermatopathologist. Each characteristic was weighted equally and each specimen was assigned a cumulative subscale score of 0-5. The scores were summed for a total score (range: 0-20) which is presented here. Higher scores indicate a higher degree of pathology. A quantitatively higher negative change indicates a more favorable therapeutic response in the histology.	Baseline; Month 4
Primary	Part 3: Measurement of Skin Thickness	Caliper-measured skin thickness (mm) was serially assessed and pre-to-post paired analysis was performed for both arms (Placebo and Ketoprofen) of the study.	Baseline and 4 months
Secondary	Part 2: Measurement of Skin Thickness	Caliper measured skin thickness (mm) of lymphedema-affected limb was serially assessed and pre-to-post paired analysis was performed.	Baseline and 4 months
Secondary	Part 3: Change From Baseline in Cutaneous Histological Architecture	Quantitative assessment of paired histological specimens of lymphedema skin pre- and post-treatment with ketoprofen or placebo, respectively. The impact of treatment on cutaneous histopathology was evaluated through the use of an empirically-derived scoring system (comprised of dermal thickness, intercellular mucin content, deep dermal collagen content, and perivascular infiltrate); this quantitative assessment was developed and performed by a dermatopathologist. Each characteristic was weighted equally and each specimen was assigned a cumulative subscale score of 0-5. The scores were summed for a total score (range: 0-20) which is presented here. Higher scores indicate a higher degree of pathology. For the analysis, the 4-month post-minus-pre change in this score for ketoprofen- and placebo-recipients, respectively, was compared. A quantitatively higher negative change indicates a more favorable therapeutic response in the histology.	Baseline; 4 months
Secondary	Part 2/Part 3: Change From Baseline in Bioimpedance Spectroscopy	A four-electrode configuration was used to non-invasively assess the extracellular and intracellular fluid contents of the limb. Data were analyzed according to Cole theory, using the manufacturer's software (Impedimed Ltd.), to provide values for a bioimpedance ratio (Ro), the resistance of the extracellular fluid including lymph, R8 the resistance of total tissue fluid and Ri, the resistance of the intracellular fluid. For the purposes of these investigations, in patients with unilateral lymphedema, the ratio of Ro in the affected:unaffected limbs was analyzed in each patient, as a measure of the bioimpedance attributable to the extracellular fluid content. An Ro level of 1.034 was considered normal; values =1.034 were considered abnormal.	Baseline; 4 months
Secondary	Part 2/Part 3: Change in Limb Volume	Quantitative assessment of limb volume (ml) of the affected limb at study end compared to pre-treatment values.	Baseline; 4 months
Secondary	Part 3: Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF)	The systemic inflammatory response of G-CSF, in the two treatment groups, Ketoprofen and Placebo, will be assessed with Luminex-bead inflammasome analysis of pre- and 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) was employed.	Baseline; 4 months

External Links

•   Stanford Health Care: Center for Lymphatic and Venous Disorders