Combined Therapies for Lymphedema Management

Overseen by Manus M Donahue, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vanderbilt University Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if using a gentle suction device along with standard therapy is more effective for reducing swelling in patients with arm or upper body lymphedema after cancer treatments. The suction helps soften hardened tissue, making it easier for massage and compression techniques to reduce swelling. A similar method has been shown to be a safe and reliable way to reduce excess fat in chronic arm lymphedema following breast cancer treatment.

Research Team

Manus M Donahue, PhD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for women who have arm or upper quadrant lymphedema after cancer treatment. They can't join if they have non-MRI compatible implants, metal fragments in their body, are pregnant (excluded only from MRI), have open wounds on ankles/feet, heart pacemakers, ferromagnetic bioimplants that could move, or had pre-existing lymphedema before cancer treatments.

Inclusion Criteria

I am a woman with swelling in my arm or upper body after cancer treatment.

Exclusion Criteria

Subjects who have any type of non-MRI compatible bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.) or are not able to comfortably be able to tolerate the limited fit of the MRI

You have metal fragments in or near your eyes, possibly from an injury or a job that involves working with metal.

I have swelling in both arms or upper body before cancer treatment.

Treatment Details

Interventions

• CDT alone (Procedure)
• CDT with Negative Pressure (Procedure)

Trial Overview The study is testing whether using negative pressure therapy with complete decongestive therapy (CDT) works better than CDT alone for managing secondary lymphedema. It's a repeated-measures cross-over trial where participants will experience both interventions sequentially.

Participant Groups

Group I: CDT with Negative Pressure Experimental Treatment 1 Intervention

CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)

Group II: CDT alone Active Control 1 Intervention

CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Dr. Jessica Gill

National Institute of Nursing Research (NINR)

Chief Medical Officer since 2023

PhD in Nursing from Johns Hopkins University

Dr. Shannon Zenk

National Institute of Nursing Research (NINR)

Chief Executive Officer since 2020

PhD in Urban Planning and Policy Development from Rutgers University