A Pilot Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer
University of Florida
Summary
Breast cancer is estimated to affect approximately 300,000 women in the US in 2023. Studies demonstrate that 1 in 5 will develop breast cancer related lymphedema secondary to the treatments that they receive. BCRL at this time has no cure, however early detection can prevent the progression to late stage BCRL. At this time a technique of arm massage, manual lymphatic drainage (MLD), is used for treatment. This study investigates a new method of MLD, which is guided by the individual patients' lymphatic anatomy through use of ICG-lymphography.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults ≥ 18 years of age * Patients undergoing axillary lymph node dissection with or without lymphatic reconstruction at diagnosis * Patients must have ICG lymphatic mapping performed prior to axillary lymph node dissection * A clinical diagnosis consistent with stage Tis-T4N0-3M0 breast cancer. * ECOG Performance Status of 0-1 * Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment…
Interventions
- ProcedureICG-guided manual lymphatic drainage
Participants will perform manual lymphatic drainage on their affected arm using ICG lymphography images of the lymphatic pathway in their affected arm as guidance once daily for 2 years post-surgery.
- ProcedureTraditional manual lymphatic drainage
Participants will perform manual lymphatic drainage on their affected arm using traditional technique once daily for 2 years post-surgery.
- DrugIndocyanine green
All participants will be injected with indocyanine green for lymphatic mapping of the affected upper extremity, however this mapping will only be used to guide manual lymphatic drainage for participants on the ICG-guided manual lymphatic drainage arm.
Location
- University of FloridaGainesville, Florida