This phase III trial compares immediate lymphatic reconstruction after axillary lymph node dissection to axillary lymph node dissection alone in decreasing the incidence of lymphedema in patients with breast cancer. Lymph nodes are found throughout the body, and they contain lymph, a milky fluid that is made up of white blood cells (cells that help fight infections). When lymph nodes in the armpit (axillary lymph nodes) are removed during breast cancer surgery, some of the lymph vessels can leak and become blocked. This may prevent lymph from leaving the area. Lymphedema occurs when lymph collects in the arm (including the hand), causing it to swell. Performing immediate surgery to reconstruct lymphatic drainage of the arm (immediate lymphatic reconstruction) after axillary lymph node dissection may reduce the chance of developing lymphedema and improve quality of life compared to axillary lymph node dissection alone.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04241341.
PRIMARY OBJECTIVE:
I. Determine if immediate lymphatic reconstruction (ILR) decreases the development of lymphedema, diagnosed as a 10% difference in arm volume compared to the contralateral arm, in patients treated for breast cancer with axillary lymph node dissection (ALND), at 24 months post-ILR.
SECONDARY OBJECTIVES:
I. Determine, in the subgroup of radiated patients, if ILR following ALND and radiation is an effective means of decreasing the development of lymphedema, diagnosed as a 10% difference in arm volume compared to the contralateral arm.
II. Determine, in the subgroup of only patients who receive ILR following ALND, if radiation has an effect on development of lymphedema, diagnosed as a 10% difference in arm volume compared to the contralateral arm.
III. Determine the efficacy of ILR in decreasing the development of lymphedema in patients treated for breast cancer with ALND using other objective measurements.
IV. Determine the efficacy of ILR in improving the quality of life of patients treated for breast cancer with ALND using subjective measures.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo ALND. Patients then receive indocyanine green solution intradermally (ID) and undergo ILR over 60 minutes.
GROUP II: Patients undergo ALND.
After completion of study treatment, patients are followed up at 6 weeks and at 6, 12, 18, and 24 months.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorMichelle Coriddi
