The purpose of this study is to evaluate the effectiveness of bevacizumab in women with lymphedema as a result of previous treatment for breast cancer.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Bevacizumab 15 mg/kg IV every 21 days
Indiana University Cancer Center
Indianapolis, Indiana, United States
Arm Volume
Time frame: baseline, Day 1, Day 22, q 6wks, termination
The affected and unaffected arm measured at five defined points:
Time frame: baseline, Day 1, Day 22, q 6wks, termination
each hand just distal to the thumb
Time frame: baseline, Day 1, Day 22, q 6wks, termination
each wrist at its narrowest point
Time frame: baseline, Day 1, Day 22, q 6wks, termination
each arm 30 cm proximal to the tip of the middle finger
Time frame: baseline, Day 1, Day 22, q 6wks, termination
each arm 40 cm proximal to the tip of the middle finger
Time frame: baseline, Day 1, Day 22, q 6wks, termination
each arm 50 cm proximal to the tip of the middle finger (if possible before the axilla is reached.)
Time frame: baseline, Day 1, Day 22, q 6wks, termination
The volume of each arm will be calculated from these measurements using the Casley Smith method29. Treatment will be considered efficacious if there is a greater than or equal to 25% decrease in excess arm volume (affected arm volume minus unaffected arm
Time frame: baseline, Day 1, Day 22, q 6wks, termination
Patients will initially be treated for 42 days (6 weeks).
Time frame: Day 1-42
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