RecruitingRecruiting
Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma
NCT03941756 · M.D. Anderson Cancer Center
In plain English
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Official title
Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study
About this study
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.
Eligibility 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.
Study design
Enrollment target: 252 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2018-08-14
Estimated completion: 2027-12-01
Last updated: 2026-05-26
Interventions
Drug: Indocyanine GreenProcedure: LymphangiographyProcedure: Lymphovenous Bypass
Primary outcomes
- • Volumetric diagnosis of lymphedema (18 months)
- • Incidence of lymphedema (18 months)
Sponsor
M.D. Anderson Cancer Center · other
With: National Cancer Institute (NCI)
Contacts & investigators
InvestigatorMark Schaverien · principal_investigator, M.D. Anderson Cancer Center
All locations (1)
M D Anderson Cancer CenterRecruiting
Houston, Texas, United States