Lymphedema Study for Arm or Leg Lymphedema

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2017-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1: Exploratory Group

Ketoprofen 225-300 mgs daily, taken orally

Ketoprofen-exploratory group: 225-300 mgs daily for four to six months

Group Type EXPERIMENTAL

Ketoprofen

Intervention Type DRUG

Part 2: Open-label Group

Ketoprofen 225 mg daily, taken orally

Open-label group: 75 mgs, three times daily, for four months

Group Type EXPERIMENTAL

Ketoprofen

Intervention Type DRUG

Part 3: Placebo Group

Participants randomized to receive placebo: placebo, three times daily, taken orally

Placebo: 1 capsule, three times daily, for four months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match ketoprofen.

Part 3: Ketoprofen Group

Participants randomized to receive active medication: ketoprofen 75 mgs., three times daily, taken orally

Ketoprofen: 1 capsule, three times daily, for four months

Group Type ACTIVE_COMPARATOR

Ketoprofen

Intervention Type DRUG

Interventions

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Ketoprofen

Intervention Type DRUG

Placebo

Placebo to match ketoprofen.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No