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.
Full Title of Study: “Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy in Patients With Inflammatory Breast Cancer: A Prospective, Randomized Study”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: December 31, 2020
I. To evaluate the protective benefit to performing lymphovenous bypass (LVB) surgery at the time of axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity.
I. Compare the medical outcomes for patients receiving LVB surgery with those receiving standard surgery without the intervention.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive indocyanine green intravenously (IV) and undergo lymphangiography, then undergo LVB at the time of ALND.
GROUP II: Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
After completion of study, patients are followed up at 2 weeks, and then at 6, 12, and 18 months.
- Drug: Indocyanine Green
- Given IV
- Procedure: Lymphangiography
- Undergo lymphangiography
- Procedure: Lymphovenous Bypass
- Undergo LVB
Arms, Groups and Cohorts
- 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.
Clinical Trial Outcome Measures
- Volumetric diagnosis of lymphedema
- Time Frame: 18 months
- If the limb volume change, meets the criteria for a diagnosis of lymphedema at any time (5 percent, change), then the patient receives a diagnosis of lymphedema.
- Incidence of lymphedema
- Time Frame: 18 months
- Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.
Participating in This Clinical Trial
- 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.
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
- Provider of Information About this Clinical Study
- Overall Official(s)
- Mark Schaverien, Principal Investigator, M.D. Anderson Cancer Center
- Overall Contact(s)
- Mark Schaverien, 713-794-1247, email@example.com
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