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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03941756
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	M.D. Anderson Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mark Schaverien
Principal Investigator Affiliation	M.D. Anderson Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Anatomic Stage III Breast Cancer AJCC v8, Breast Inflammatory Carcinoma, Locally Advanced Breast Carcinoma, Melanoma

Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Drug: - Indocyanine Green

Given IV

Procedure: - Lymphangiography

Undergo lymphangiography

Procedure: - Lymphovenous Bypass

Undergo LVB

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Mark Schaverien

[email protected]

832-499-6321

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