RightFit
RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether lymphovenous bypass before underarm lymph node surgery can prevent arm swelling called lymphedema. The procedure makes a new path for fluid to drain from the arms. It is for people with inflammatory breast cancer, other breast cancer that has spread nearby, or melanoma.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Willing to join and able to give informed consent, meaning you understand and agree to take part.
  • Meet one of these two cancer groups:
  • Have inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes, with planned underarm lymph node removal and expected radiation treatment.
  • Or have melanoma, including melanoma with no known starting site, with planned underarm lymph node removal. This group is used for comparison.

Who can't join

  • Have taken blood thinners within 7 days before surgery.
  • Are known to be pregnant at the time of surgery.
  • Cannot take part in follow-up for at least 18 months or do not have measurements taken on schedule.
  • Have a body mass index (BMI), a measure based on height and weight, over 50.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

TX