Overview

Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer

Status:
Recruiting
Trial end date:
2020-12-31
Target enrollment:
0
Participant gender:
All
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. 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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Criteria
Inclusion Criteria:

- Patients willing to participate.

- Patients able to complete informed consent.

- 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.

Exclusion Criteria:

- Patients taking anticoagulants within 7 days prior to surgery.

- Patients that are known to be pregnant at the time of surgery.

- Patients are available for follow-up less than 18 months.

- Patients with known iodine hypersensitivity.

- Patients with known hypersensitivity to indocyanine green (ICG).

- Patients with body mass index (BMI) greater than 40.0.