NCT05992909

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

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
15mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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

Study Progress69%
Aug 2023Aug 2027

Study Start

First participant enrolled

August 2, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

4 years

First QC Date

August 4, 2023

Last Update Submit

November 6, 2025

Conditions

Lymphadenectomy

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03

    through study completion; an average of 1 year

Study Arms (1)

Lymphovenous bypass procedure (LBP)

A surgical procedure for treating lymphedema called lymphovenous bypass procedure (LBP), but it is usually only done after a patient develops lymphedema

Procedure: Lymphovenous bypass procedure

Interventions

Lymphovenous bypass procedurePROCEDURE

Participants will return to the clinic 14 days, 6 months, 12 months, 18 months, and 24 months after your surgery for measurements of your legs to see if there are changes over time

Lymphovenous bypass procedure (LBP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

M D Anderson Cancer Center

You may not qualify if:

  • 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 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

RECRUITING

Related Links

Study Officials

  • Ashleigh Francis, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashleigh Francis, MD

CONTACT

713-563-4598amfrancis@mdanderson.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 15, 2023

Study Start

August 2, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

November 10, 2025

Record last verified: 2025-11

Locations

US(1)