Conditions: Lymphedema Unspecified Adult Solid Tumor, Protocol Specific
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 14
Healthy volunteers: no

Brief summary:
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:
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.

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: placebo for study drug intervention 2: (RS)2-(3-benzoylphenyl)-propionic acid intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies

Protocol document: