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Compression Therapy vs Manual Lymphatic Drainage for Lymphedema (SLT Trial)

N/A

Waitlist Available

Led By Megan T Klote, DPT, CLT-LANA

Research Sponsored by Mercy Research

Eligibility Criteria Checklist

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

Must have

Female, 18 years of age or older

Upcoming unilateral axillary lymph node procedure (biopsy or dissection)

Must not have

Acute Deep Vein Thrombosis

Unmanaged congestive heart failure or a cardiac event in the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of two treatment protocols for patients with breast cancer-related subclinical lymphedema.

Who is the study for?

This trial is for women over 18 with a new breast cancer diagnosis who are about to have surgery on underarm lymph nodes. They must be able to consent and haven't had previous lymph node surgeries, severe liver or kidney disease, heart issues in the last 6 months, a pacemaker, active infections, current deep vein thrombosis, pregnancy or existing lymphedema.

What is being tested?

The study compares two treatments for early-stage swelling (subclinical lymphedema) after breast cancer surgery: wearing a compression sleeve and gauntlet versus manual drainage of the lymph system. Participants will be randomly assigned to one of these treatments if they show changes in arm volume post-surgery.

What are the potential side effects?

Potential side effects may include discomfort from wearing the compression sleeve and possible skin irritation. Manual Lymphatic Drainage might cause temporary swelling or tenderness in treated areas.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman aged 18 or older.

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I am scheduled for a lymph node procedure in my armpit.

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I have been recently diagnosed with breast cancer.

Exclusion Criteria

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

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I have a recent deep vein blood clot.

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I have not had uncontrolled heart failure or a heart event in the last 6 months.

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I have had a procedure or radiation on my underarm lymph nodes.

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My kidney disease is in stage 4 or 5.

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I have severe liver disease.

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I have been diagnosed with lymphedema by a doctor.

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I currently have an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Therapy GroupExperimental Treatment2 Interventions

Subjects in the Therapy Group will wear 20-30 mmHg sleeves and gauntlets daily and receive Manual Lymphatic Drainage 3x/week for a maximum of 4 weeks. L-dex will be performed at the end of each week. If the L-dex score has reversed back into normal range, intervention will be discontinued and the subject will resume the surveillance schedule of screenings. If the L-dex score is abnormal, intervention continues. If L-dex score is abnormal even at the end of the 4 weeks, the subject will be removed from the study and referred to standard lymphedema therapy. An abnormal L-dex is defined by 7 or more units change compared to the subject's pre-surgical baseline.

Group II: Compression GroupActive Control1 Intervention

Subjects in the Compression Group will wear 20-30 mmHg sleeves and gauntlets daily for a maximum of 4 weeks. L-dex will be performed at the end of each week. If the L-dex score has reversed back into normal range, intervention (garment wearing) will be discontinued and the subject will resume the surveillance schedule of screenings. If the L-dex score is still abnormal, garment wearing continues. If L-dex score is abnormal even at the end of the 4 weeks, the subject will be removed from the study and referred to standard lymphedema therapy. An abnormal L-dex is defined by 7 or more units change compared to the subject's pre-surgical baseline.

0 / 10Eligibility criteria met