Compression Therapy vs Manual Lymphatic Drainage for Lymphedema

(SLT Trial)

Overseen by Megan T Klote, DPT, CLT-LANA

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mercy Research

No Placebo Group

Trial Summary

What is the purpose of this trial?

Primary Objective * To compare the effectiveness of 2 treatment protocols for patients with breast cancer-related subclinical lymphedema identified through bioimpedance spectroscopy, L-dex scores Secondary Objectives * To determine the necessary duration of intervention to reverse L-dex scores back to a normal range in patients with breast cancer-related subclinical lymphedema * To determine the time elapsed post-surgically to the development of subclinical lymphedema identified by bioimpedance spectroscopy, L-dex scores * To identify risk factors for the development of subclinical lymphedema in patients with breast cancer * To identify factors associated with the progression to clinical lymphedema following treatment of subclinical lymphedema as identified by bioimpedance spectroscopy, L-dex scores Women with breast cancer diagnoses and planned axillary lymph node procedures will receive pre-operative screening of arm volume with bioimpedance, which will capture baseline measurements. Then, subjects will undergo periodic screenings for the first 3 years following surgery. If a significant change in volume compared to baseline is detected with bioimpedance, subjects will be randomized to 1 of 2 treatment groups. The outcomes of 2 treatment protocols will be compared. Additionally, subjects will be screened each week during their treatment interventions to determine the necessary quantity of intervention before L-dex scores normalize.

Research Team

Megan T Klote, DPT, CLT-LANA

Principal Investigator

Mercy Research

Eligibility Criteria

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.

Inclusion Criteria

I am a woman aged 18 or older.

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

Able to provide informed consent

Exclusion Criteria

I have a recent deep vein blood clot.

You have a pacemaker or other implanted electrical device.

Pregnancy

Treatment Details

Interventions

• 20-30 mmHg compression sleeve and gauntlet (Other)
• Manual Lymphatic Drainage (Other)

Trial Overview 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.

Participant Groups

Group I: Therapy Group Experimental Treatment 2 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

Mercy Research

Lead Sponsor

Trials

21

Recruited

1,400+

ImpediMed Limited

Industry Sponsor

Trials

10

Recruited

1,800+

Mercy Foundation

Collaborator

Trials

1

Recruited

270+

St. Louis Men's Group Against Cancer

Collaborator

Trials

1

Recruited

270+

Juzo USA

Collaborator

Trials

1

Recruited

270+