NCT03941756 Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma
| NCT ID | NCT03941756 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Anatomic Stage III Breast Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 252 participants |
| Start Date | 2018-08-14 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 252 participants in total. It began in 2018-08-14 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Mark Schaverien
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT03941756 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anatomic Stage III Breast Cancer AJCC v8. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03941756 currently recruiting?
Yes, NCT03941756 is actively recruiting participants. Visit ClinicalTrials.gov or contact M.D. Anderson Cancer Center to inquire about joining.
Where is the NCT03941756 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT03941756 clinical trial?
NCT03941756 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Mark Schaverien at M.D. Anderson Cancer Center. The trial plans to enroll 252 participants.
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