Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema in High Risk Patients

Conditions
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Lymphedema, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: placebo for study drug
* Drug: (RS)2-(3-benzoylphenyl)-propionic acid
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (RS)2-(3-benzoylphenyl)-propionic acid<br>Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity. Laboratory biomarker analysis will be performed. | Drug: (RS)2-(3-benzoylphenyl)-propionic acid<br>* Given PO<br>* Other names: BPA;Other: laboratory biomarker analysis<br>* Correlative studies<br>|
| Placebo Comparator: placebo for study drug<br>Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity. Laboratory biomarker analysis will be performed. | Drug: placebo for study drug<br>* Given PO<br>* Other names: PLCB;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Incidence of Lymphedema | Participants were evaluated every 3 months up to one year post lymph node dissection | Up to 1 year |