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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03941756
• Other study ID #: 2018-0127
• Secondary ID: NCI-2019-0232020
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES: I. To evaluate the protective benefit to performing standard of care lymphovenous bypass (LVB) surgery at the time of standard of care axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity. SECONDARY OBJECTIVES: I. Compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

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 or do not undergo measurements within the scheduled period.
• Patients with body mass index (BMI) greater than 50.0.

Related Conditions & MeSH terms

• Anatomic Stage III Breast Cancer AJCC v8
• Breast Inflammatory Carcinoma
• Breast Neoplasms
• Carcinoma
• Locally Advanced Breast Carcinoma
• Melanoma

Intervention

Drug:
• Indocyanine Green
Given IV

Procedure:
• Lymphangiography
Undergo lymphangiography
• Lymphovenous Bypass
Undergo LVB

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volumetric diagnosis of lymphedema	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.	18 months
Primary	Incidence of lymphedema	Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.	18 months