Lymphedema is a chronic, progressive, and debilitating condition that occurs with disruption or obstruction of the lymphatic system, which commonly occurs a result of breast cancer therapy. The purpose of this study is to determine if the use of a low risk lymphatic reconstruction procedure at the time of axillary lymph node dissection will reduce the risk of developing lymphedema. Additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins
oncologic axillary lymphadenectomy
axillary lymphadenectomy with soft tissue reinforcement(STR)
Stanford Cancer Institute
San Francisco, California, United States
RECRUITINGLymphatic flow pattern of whole limb
In the early lymphedema stages this exam allows to detect percutaneously the lymphatic vessels of the whole limb, up to about 1 cm in depth from the skin surface, by an infrared camera visualization system after intra-dermal injection of ICG in the hand. The change in the lymphatic pattern and reduction in the ICG velocity will be tested to find a correlation with other used diagnostic parameters like volume change and bioimpedance spectroscopy.
Time frame: 2 yr
Limb Volume
Limb volume as measured by serial assessment
Time frame: 2 yr
Skin thickness measurements
Skin thickness is changed by lymphedema
Time frame: 2 yr
Bioiimpedance spectroscopy
Impedance of the skin changes with lymphedema
Time frame: 2 yr
Quality of life
Questionnaire to determine patient reported quality of life. Measured by limb-lymphedema-specific quality of life (LYMQOL) tool. The LYMQOL is divided into four domains: Function, Appearance, Symptoms, and Mood, as well as yielding an overall quality-of-life score
Time frame: 2 yr
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.