Lymphedema Study for Arm or Leg Lymphedema

NCT02257970 | Completed Phase 4 Results

• 1 other identifier: 7781
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphedema

Keywords

Lymphedema; edema; swelling

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Part 2: Measurement of Skin Thickness

  Baseline and 4 months

• Part 3: Change From Baseline in Cutaneous Histological Architecture

  Baseline; 4 months

• Part 2/Part 3: Change From Baseline in Bioimpedance Spectroscopy

  Baseline; 4 months

• Part 2/Part 3: Change in Limb Volume

  Baseline; 4 months

• Part 3: Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF)

  Baseline; 4 months

Study Arms (4)

Part 1: Exploratory Group

EXPERIMENTAL

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

Drug: Ketoprofen

Part 2: Open-label Group

EXPERIMENTAL

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

Drug: Ketoprofen

Part 3: Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo

Part 3: Ketoprofen Group

ACTIVE COMPARATOR

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

Drug: Ketoprofen

Interventions

Ketoprofen DRUG

Part 1: Exploratory Group; Part 2: Open-label Group; Part 3: Ketoprofen Group

Placebo DRUG

Placebo to match ketoprofen.

Part 3: Placebo Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 30333315 DERIVED

Related Links

• Stanford Health Care: Center for Lymphatic and Venous Disorders

MeSH Terms

Conditions

Lymphedema; Edema

Interventions

Ketoprofen

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Stanley Rockson
• Organization: Stanford University, School of Medicine

rockson@stanford.edu

650-725-7571

Study Officials

• Stanley G Rockson, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Allan and Tina Neill Professor of Lymphatic Research and Medicine; Professor of Cardiovascular Medicine

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: October 7, 2014
• Study Start: March 1, 2009
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: October 27, 2022
• Results First Posted: September 14, 2018

Record last verified: 2022-10

Locations

US (1)