This clinical trial evaluates whether performing lymphovenous bypass (LVB) during axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) works for the prevention of lymphedema (LE) in melanoma patients. LE is a common, chronic, and debilitating condition caused by a collection of fluid in an arm or leg. Removal of lymph nodes can often lead to LE. LE results in swollen limbs, often progressing to chronic pain and fibrosis. The swelling can have a big impact on patients’ everyday lives and can also place a patient at a higher risk for developing infections. LVB is a surgical procedure in which lymphatic vessels are connected to the veins, creating alternative pathways for lymphatic fluid to flow out from obstructed channels in the limb. Typically, LVB is only done after a patient develops LE. Performing LVB during ALND or ILND may be effective in preventing the development of LE in melanoma patients.
Additional locations may be listed on ClinicalTrials.gov for NCT06887205.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Approved
Contact: Ashleigh M. Francis
Phone: 713-819-1984
PRIMARY OBJECTIVE:
I. To examine if performing lymphovenous bypass (LVB) at the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma patient population impacts the period prevalence of lymphedema occurrence one year from surgery.
SECONDARY OBJECTIVES:
I. To assess wound complications rates occurring in first 30-days post operatively from the time of surgery.
II. To estimate time to drain removal.
III. To estimate the point prevalence of LE following surgery at 3 months, 6 months, and 1 year following surgery.
IV. To estimate the cumulative incidence associated with the first appearance of LE.
V. To assess quality of life and survivorship, using Lymphedema Quality of Life (LYMQOL) questionnaire over the study follow-up domain.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive dye intradermally and undergo reverse lymph node mapping during standard of care (SOC) ALND. Patients then undergo LVB.
COHORT II: Patients receive dye intradermally and undergo reverse lymph node mapping during SOC ILND. Patients then undergo LVB.
After completion of study intervention, patients are followed up every 2-4 weeks for the first 2 months and then at months 3, 6, and 12.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorAshleigh M. Francis
