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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years post-operatively

Awards & highlights

SLT Trial 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.Check my eligibility

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.See study design

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.

SLT Trial 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.

SLT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years post-operatively for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

L-dex scores

SLT 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ImpediMed LimitedIndustry Sponsor

9 Previous Clinical Trials

1,560 Total Patients Enrolled

Mercy ResearchLead Sponsor

19 Previous Clinical Trials

1,150 Total Patients Enrolled

Mercy FoundationUNKNOWN

Media Library

20-30 mmHg compression sleeve and gauntlet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03292198 — N/A

Breast Cancer Subclinical Lymphedema Research Study Groups: Therapy Group, Compression Group

Breast Cancer Subclinical Lymphedema Clinical Trial 2023: 20-30 mmHg compression sleeve and gauntlet Highlights & Side Effects. Trial Name: NCT03292198 — N/A

20-30 mmHg compression sleeve and gauntlet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03292198 — N/A

Frequently Asked Questions

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

For what number of participants is this experiment recruiting?

"Affirmative. According to clinicaltrials.gov, this trial is currently recruiting participants and was posted on April 1st 2018 with the most recent update occurring 18 days ago on April 18th 2022. A total of 267 patients are needed from a single location."

Answered by AI

Are there any current opportunities to participate in this experiment?

"Affirmative, clinicaltrials.gov indicates that the study is actively recruiting patients. This research was first posted on April 1st 2018 and most recently modified on April 18th 2022. The experiment requires 267 individuals from a single site to be enrolled in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Subclinical Lymphedema Treatment Study

Megan Klote 2018. "Subclinical Lymphedema Treatment Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03292198.

All > Breast Cancer Hawaii > Lymphedema