Melanoma Clinical Trial
Official title:
Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study
Verified date | May 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 252 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Volumetric diagnosis of lymphedema | If the limb volume change, meets the criteria for a diagnosis of lymphedema at any time (5 percent, change), then the patient receives a diagnosis of lymphedema. | 18 months | |
Primary | Incidence of lymphedema | Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques. | 18 months |
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