Lymphovenous bypass to prevent lymphedema in breast cancer and melanoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Mark Schaverien — M.D. Anderson Cancer Center

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Personalized Exercise Plan for Breast Cancer Survivors on Chemotherapy

  This trial tests whether adding a guided exercise program to a healthy-lifestyle education plan helps breast cancer patients undergoing chemotherapy maintain fitness, heart health, and quality of life.

  Recruiting at 3 sites Wake Forest University Health Sciences · Winston-Salem, North Carolina and 3 other locations · NCT07474090

• Safety of combining pidnarulex (CX-5461) with trastuzumab deruxtecan for HER2-positive, HER2-low/ultralow breast and other HER2-expressing solid tumors

  This trial tests whether adding pidnarulex to trastuzumab deruxtecan is safe and finds the best dose for adults with HER2-positive, HER2-low/ultralow, or other HER2-expressing advanced or metastatic breast and solid tumors.

  Recruiting at 2 sites Phase 1 National Cancer Institute (NCI) · Boston, Massachusetts and 1 other locations · NCT07137416

• Optimized ultrasound twinkling marker to image axillary lymph nodes in clinically node-positive breast cancer

  This trial tests an improved ultrasound twinkling marker to help doctors reliably see cancer-containing lymph nodes by ultrasound in people with biopsy-proven node-positive breast cancer.

  Recruiting Phase 1 Mayo Clinic · Rochester, Minnesota · NCT06999798

• Melanoma treatment with immunotherapy guided by serial ctDNA testing

  This trial tests whether regular ctDNA blood tests during treatment can help tailor the plan for patients with advanced melanoma receiving nivolumab and ipilimumab.

  Recruiting Phase 2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07930182

• Non-invasive skin-tape test to detect melanoma using methylation biomarkers

  A non-invasive skin-tape test is being tried to see if it can detect melanoma in people who are about to have a biopsy for a suspicious pigmented lesion.

  Recruiting at 4 sites Mitra Bio · Ghent and 4 other locations · NCT07883954

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.