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Combined Therapies for Lymphedema Management

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will test whether a combination of therapies is more effective than one therapy alone for secondary lymphedema management.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessing a Change in Bioimpedance Spectroscopy (BIS)

Secondary outcome measures

Assessing a Change in Limb Volume

Assessing a Change in Lymphatic Stasis

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,149 Total Patients Enrolled

3 Trials studying Lymphedema

335 Patients Enrolled for Lymphedema

National Institutes of Health (NIH)NIH

2,700 Previous Clinical Trials

7,506,832 Total Patients Enrolled

2 Trials studying Lymphedema

304 Patients Enrolled for Lymphedema

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

10,376,517 Total Patients Enrolled

Media Library

CDT alone Clinical Trial Eligibility Overview. Trial Name: NCT03760744 — N/A

Lymphedema Research Study Groups: CDT with Negative Pressure, CDT alone

Lymphedema Clinical Trial 2023: CDT alone Highlights & Side Effects. Trial Name: NCT03760744 — N/A

CDT alone 2023 Treatment Timeline for Medical Study. Trial Name: NCT03760744 — N/A

Lymphedema Patient Testimony for trial: Trial Name: NCT03760744 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment to this research still open?

"Clinicaltrials.gov confirms that this treatment is actively being sought out for participants, with initial posting on January 23rd 2019 and last update occuring April 12th 2022."

Answered by AI

What are the qualifications to participate in this trial?

"Patients who have been diagnosed with lymphedema and between the ages of 30 to 90 are qualified for this clinical trial. A total of 44 persons will be enrolled in the study."

Answered by AI

Is eligibility for this clinical trial limited to individuals under 45 years of age?

"Eligibility criteria for this clinical trial includes individuals who are older than 30 but younger than 90 years old."

Answered by AI

How many individuals have signed up for this exploration?

"Affirmative. According to the data presented on clinicaltrials.gov, this research study is actively searching for patients as of April 12th 2022, shortly after its initial posting on January 23rd 2019. The trial seeks 44 participants from a single medical site."

Answered by AI