What side effects are associated with this type of intervention?

Common treatments for lymphedema, such as Complete Decongestive Therapy (CDT) and Intermittent Pneumatic Compression (IPC), generally have a low rate of severe side effects. Minor complications can include delayed wound healing, lymphatic fistula, and minor infections. Surgical options like lymphovenous bypass may result in minor complications such as surgical site infections, lymph leaks, and the need for reexploration due to flap congestion. Reductive techniques, which involve the removal of fibrofatty tissue, can also lead to minor complications but are generally well-tolerated. Overall, these treatments are effective in reducing limb volume and improving quality of life with manageable side effects.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for the treatment of lymphedema. However, it discusses various therapies such as complete decongestive therapy (CDT), intermittent pneumatic compression (IPC), and advanced pneumatic compression devices (APCD). These treatments aim to reduce limb volume and improve lymphatic drainage, similar to the goals of Graded Negative Pressure Therapy. CDT combines lymph drainage, compression bandaging, exercise, and skin care, while IPC and APCD use mechanical compression to enhance lymphatic flow. These therapies have shown benefits in clinical trials and retrospective reviews, indicating their effectiveness in managing lymphedema.

What other types of research exist?

Promising novel alternatives to Graded Negative Pressure Therapy for lymphedema patients include the use of complete decongestive therapy (CDT) combined with other modalities such as hyperbaric oxygen therapy (HBO) and advanced wound care techniques like the use of hyaluronic acid and sodium alginate dressings. These treatments have shown potential in improving tissue health and promoting healing, which could be beneficial for lymphedema management.

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Combined Therapies for Lymphedema Management

N/A

Waitlist Available

Led By Manus M Donahue, PhD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females with a diagnosis of secondary arm and/or upper quadrant lymphedema following cancer treatments

Be older than 18 years old

Must not have

Persons with bilateral arm lymphedema (or bilateral risk) or pre-existing lymphedema/edema in the upper body prior to cancer treatments.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and at 6-8 weeks following the completion of each therapy

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort due to the negative pressure application and possible skin irritation from electrodes used during assessments. The exact side effects of the therapies being tested were not provided.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and at 6-8 weeks following the completion of each therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and at 6-8 weeks following the completion of each therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and at 6-8 weeks following the completion of each therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessing a Change in Bioimpedance Spectroscopy (BIS)

Secondary study objectives

Assessing a Change in Limb Volume

Assessing a Change in Lymphatic Stasis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CDT with Negative PressureExperimental Treatment1 Intervention

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

Group II: CDT aloneActive Control1 Intervention

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lymphedema treatments often focus on improving lymphatic drainage and reducing tissue swelling. Complete Decongestive Therapy (CDT) combines manual lymphatic drainage, compression therapy, exercise, and skin care to enhance lymph flow and reduce edema. Graded Negative Pressure Therapy, studied in conjunction with CDT, mobilizes protein-enriched hardened tissue, potentially improving lymphatic drainage and reducing swelling more effectively than CDT alone. These treatments are crucial for lymphedema patients as they help manage symptoms, prevent complications, and improve quality of life by reducing limb volume and discomfort.

Effect of electrically induced muscle contractions on posttraumatic edema formation in frog hind limbs.On physiological edema in man's lower extremity.Muscle fiber conduction velocity and EMG amplitude of the upper trapezius muscle in healthy subjects after low-level laser irradiation: a randomized, double-blind, placebo-controlled, crossover study.