NCT06887205

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 6, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

March 14, 2025

Last Update Submit

April 21, 2026

Conditions

Lymphatic ReconstructionLymphadenectomy

Outcome Measures

Primary Outcomes (1)

  • Safety and adverse events

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events

    Through study completion; an average of 1 year

Study Arms (2)

Upper extremity group recieving ALND

EXPERIMENTAL

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

Procedure: Lymphovenous bypass (LVB)

Lower extremity group getting ILND

EXPERIMENTAL

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

Procedure: Lymphovenous bypass (LVB)

Interventions

Lymphovenous bypass (LVB)PROCEDURE

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

Lower extremity group getting ILNDUpper extremity group recieving ALND

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Study Officials

  • Ashleigh M Francis, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashleigh M Francis, MD

CONTACT

(713) 413-7451amfrancis@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 20, 2025

Study Start (Estimated)

September 6, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

US(1)