Clinical trial NCT02257970: Lymphedema Study for Arm or Leg Lymphedema
Official title: Placebo-controlled, Case-controlled, Open Label Therapeutic Trial for Unilateral or Bilateral Lymphedema of Arm or Leg.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lymphedema
Keywords: Lymphedema
edema
swelling
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-10-07
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Part 1: Count of Participants Able to Complete Ketoprofen Treatment
timeFrame: Baseline to month 6
measure: Part 2: Change From Baseline in Cutaneous Histological Architecture
timeFrame: Baseline; Month 4
measure: Part 3: Measurement of Skin Thickness
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Part 2: Measurement of Skin Thickness
timeFrame: Baseline and 4 months
measure: Part 3: Change From Baseline in Cutaneous Histological Architecture
timeFrame: Baseline; 4 months
measure: Part 2/Part 3: Change From Baseline in Bioimpedance Spectroscopy
timeFrame: Baseline; 4 months
measure: Part 2/Part 3: Change in Limb Volume
timeFrame: Baseline; 4 months
measure: Part 3: Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF)
timeFrame: Baseline; 4 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Stanley G Rockson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rockson SG, Tian W, Jiang X, Kuznetsova T, Haddad F, Zampell J, Mehrara B, Sampson JP, Roche L, Kim J, Nicolls MR. Pilot studies demonstrate the potential benefits of antiinflammatory therapy in human lymphedema. JCI Insight. 2018 Oct 18;3(20):e123775. doi: 10.1172/jci.insight.123775.