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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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 with all the study-related procedures.

• Subjects of childbearing potential (SOCBP) must have a negative pregnancy test prior to enrollment and be using an adequate method of contraception to avoid pregnancy throughout study participation to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.

• Patients must undergo a baseline physical therapy evaluation prior to axillary lymph node dissection.

• Patients who have received neoadjuvant chemotherapy are required to see physical therapy for lymphedema assessment following completion of chemotherapy prior to surgery.

Locations
United States
Florida
University of Florida
RECRUITING
Gainesville
Contact Information
Primary
Judy Walsh
PMO@cancer.ufl.edu
(352) 294-8615
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2028-06
Participants
Target number of participants: 30
Treatments
Experimental: ICG-guided manual lymphatic drainage
Active_comparator: Traditional manual lymphatic drainage
Related Therapeutic Areas
Sponsors
Leads: University of Florida

This content was sourced from clinicaltrials.gov