Immediate Lymphatic Reconstruction After Lymphadenectomy in Melanoma Patients: a Parallel Cohort Pilot Study

Study Purpose

To learn if LBP can help to prevent lymphedema when it is performed at the time of surgery rather than after a patient has already developed the disease.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Participants greater than or equal to 18 years of age. 2. Participants willing to participate. 3. Participants able to complete informed consent. 4. Participants with a diagnosis of Melanoma undergoing ALND or ILND.

Exclusion Criteria:

1. Participant staking anticoagulants within 7 days prior to surgery. 2. Participants that are known to be pregnant at the time of surgery. 3. Participants with BMI greater than 50.0

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06887205
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ashleigh M Francis, MD
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lymphatic Reconstruction, Lymphadenectomy
Study Website: View Trial Website
Additional Details

To examine if performing lymphovenous bypass (LVB) at the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma participant population impacts the period prevalence of lymphedema occurrence one year from surgery. To assess wound complications rates occurring in first 30-days post operatively from the time of surgery. To estimate time to drain removal. To estimate the point prevalence of LE following surgery at 3 months, 6 months, and 1 year following surgery. To estimate the cumulative incidence associated with the first appearance of LE. To assess quality of life and survivorship, using Lymphedema Quality of Life (LYMQOL) questionnaire over the study follow-up domain.

Arms & Interventions

Arms

Experimental: Upper extremity group recieving ALND

Participants will be recruited pre-operatively by their treating physicians.

Experimental: Lower extremity group getting ILND

Participants will be recruited pre-operatively by their treating physicians.

Interventions

Procedure: - Lymphovenous bypass (LVB)

At the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma patient population.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

MD Anderson Cancer Center, Houston, Texas

Status

Address

MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Ashleigh M Francis, MD

[email protected]

713-413-7451

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