Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema

Stanford University14 enrolled

Overview

This randomized clinical trial studies an investigational drug in preventing lymphedema in patients at high risk after undergoing axillary lymph node dissection. The study drug may prevent lymphedema in patients undergoing axillary lymph node dissection.

PRIMARY OBJECTIVES: I. To evaluate the efficacy of study drug in improving chronic lymphedema while further elucidating the role of inflammatory and lymphangiogenic processes in the pathogenesis of this disease. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive study drug orally (PO) thrice daily (TID) for up to 1 year in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Lymphedema Unspecified Adult Solid Tumor, Protocol Specific

Interventions

placebo for study drugDRUG

Given PO

(RS)2-(3-benzoylphenyl)-propionic acidDRUG

Given PO

laboratory biomarker analysisOTHER

Correlative studies

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Axillary lymph node dissection within the preceding 12 months Exclusion Criteria: * Patients with active cancer * Patients with lymphedema * Infection or bleeding tendency * Patients with medical contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including history of allergies, know gastrointestinal intolerance * 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 * Persons not competent to consent * Patients on aspirin therapy * Minors (\< 18 years of age) * Pregnant and/or lactating women * Males

Locations (1)

Stanford University Hospitals and Clinics

Stanford, California, United States

Outcomes

Primary Outcomes

Number of Participants With Incidence of Lymphedema

Participants were evaluated every 3 months up to one year post lymph node dissection

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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