A Pilot Study of VEGF Inhibition in Patients With Lymphedema Following Breast Cancer Treatment
The primary objective of this study is:
• To assess the degree of improvement in arm edema as measured by changes in arm volume in
patients with ipsilateral lymphedema
The secondary objectives of this study are:
- To assess the degree of improvement in arm edema as measured by changes in arm
interstitial fluid pressure (IFP)
- To assess the degree of improvement in arm edema as measured by changes in
extracellular fluid (ECF) volume based on bioelectrical impedance analysis (BIA) by
lymphometer
- To assess the safety and tolerability of VEGF inhibition in this patient population
- To assess the clinical benefit in patients with ipsilateral lymphedema treated with
vascular endothelial growth factor (VEGF) inhibition by evaluating patient responses
to a quality of life questionnaire (FACT-B+4 lymphedema questions)
- To determine the impact of VEGF inhibition on circulating VEGF levels in patients with
lymphedema
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Arm Volume
baseline, Day 1, Day 22, q 6wks, termination
No
Kathy Miller, MD
Principal Investigator
Indiana University
United States: Food and Drug Administration
0606-24
NCT00393497
April 2007
January 2011
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |