NCT01893879

Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphedema
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	placebo for study drug	Given PO
DRUG	(RS)2-(3-benzoylphenyl)-propionic acid	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2013-07-09
• Last updated: 2017-05-18
• Results posted: 2017-05-18

Locations

1 site across 1 country: United States