A Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing I
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
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 of the investigational regimen \[as determined by the treating physician and approved by the PI\] may be included). * Written informed consent obtained from the subject and the subject agrees to comply |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Lead sponsor | University of Florida |
| Locations | Gainesville, Florida, United States |
| Start date | 2024-10-15 |
| NCT ID | NCT06327490 |
| Official listing | https://clinicaltrials.gov/study/NCT06327490 |