Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema in Patients At High Risk After Undergoing Axillary Lymph Node Dissection
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.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: study drug
Other: laboratory biomarker analysis
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema in High Risk Patients|
- Incidence of lymphedema and/or severity of lymphedema [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2014|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm I (study drug)
Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Drug: study drug
Given POOther: laboratory biomarker analysis
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Other Name: PLCBOther: laboratory biomarker analysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01893879
|United States, California|
|Stanford University Hospitals and Clinics||Not yet recruiting|
|Stanford, California, United States, 94305|
|Contact: Stanley Rockson 650-498-7061 email@example.com|
|Principal Investigator: Stanley Rockson|
|Principal Investigator:||Stanley Rockson||Stanford University Hospitals and Clinics|