Lymphovenous bypass to prevent lymphedema in breast cancer and melanoma patients
Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study
This study is testing if a special surgery called lymphovenous bypass can help prevent lymphedema in breast cancer and melanoma patients who are at high risk for this condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03941756 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates whether performing a lymphovenous bypass procedure before axillary lymph node surgery can prevent lymphedema in patients with inflammatory or locally advanced non-inflammatory breast cancer and melanoma. The study involves randomizing patients into two groups: one receiving the lymphovenous bypass along with standard surgery, and the other receiving standard surgery alone. Patients will be monitored for outcomes related to lymphedema over an 18-month follow-up period. The primary goal is to evaluate the protective benefits of the lymphovenous bypass procedure in high-risk patients.
Who should consider this trial
Good fit: Ideal candidates include adults with inflammatory breast cancer or locally advanced non-inflammatory breast cancer, as well as melanoma patients scheduled for axillary lymph node dissection.
Not a fit: Patients with a body mass index greater than 50, those taking anticoagulants, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of lymphedema in patients undergoing surgery for breast cancer or melanoma.
How similar studies have performed: While lymphovenous bypass has been studied in other contexts, this specific approach in the pre-surgical setting for these cancers is novel and has not been extensively tested.
Eligibility criteria
Show full 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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Mark Schaverien — M.D. Anderson Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.