Lymphedema Study for Arm or Leg Lymphedema

Stanford University

Status and phase: Completed; Phase 4

Conditions: Lymphedema

Treatments: Drug: Placebo; Drug: Ketoprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02257970

7781

Details and patient eligibility

About

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

Full 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.

Enrollment: 117 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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117 participants in 4 patient groups, including a placebo group

Part 1: Exploratory Group

Experimental group

Description:

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

Treatment:

Drug: Ketoprofen

Part 2: Open-label Group

Experimental group

Description:

Ketoprofen 225 mg daily, taken orally Open-label group: 75 mgs, three times daily, for four months

Treatment:

Drug: Ketoprofen

Part 3: Placebo Group

Placebo Comparator group

Description:

Participants randomized to receive placebo: placebo, three times daily, taken orally Placebo: 1 capsule, three times daily, for four months

Treatment:

Drug: Placebo

Part 3: Ketoprofen Group

Active Comparator group

Description:

Participants randomized to receive active medication: ketoprofen 75 mgs., three times daily, taken orally Ketoprofen: 1 capsule, three times daily, for four months

Treatment:

Drug: Ketoprofen