Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema — PCTTPL  

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lymphedema
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT01893879
• Study type: Interventional
• Source: Stanford University
• Status: Terminated
• Phase: N/A
• Start date: April 2014
• Completion date: April 2015