Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study

Who is this study for? Adult patients with breast cancer
What treatments are being studied? Lymphovenous Bypass
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients greater than or equal to 18 years of age.

• Patients willing to participate.

• Patients able to complete informed consent.

• Patients will be eligible for inclusion if they fall into one for two groups:

‣ Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy

⁃ Or: Patients with a diagnosis of melanoma (including unknown primary) that will undergo ALND will also be eligible for inclusion in the study as a comparator group.

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Time Frame
Start Date: 2018-08-14
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 252
Treatments
Experimental: Group I (LVB)
Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
No_intervention: Group II (no intervention)
Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov