Compression Therapy vs Manual Lymphatic Drainage for Lymphedema

(SLT Trial)

Not currently recruiting at 1 trial location

Overseen By Megan Klote, DPT, CLT-LANA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mercy Research

Disqualifiers: Lymphedema, Pregnancy, Pacemaker, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: Up to 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which treatment is more effective for women showing early signs of lymphedema (swelling due to fluid build-up) after breast cancer surgery. The trial will compare two treatments: wearing a 20-30 mmHg compression sleeve and gauntlet, or undergoing manual lymphatic drainage (a specialized massage). Women recently diagnosed with breast cancer and planning lymph node surgery may be eligible. The trial seeks to identify which approach better reverses early signs of lymphedema and to explore factors contributing to its development and progression. As an unphased trial, this study provides a unique opportunity to enhance understanding and improve early lymphedema treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these treatment protocols are safe for patients with breast cancer-related subclinical lymphedema?

Previous studies have shown that compression sleeves and gauntlets with a pressure of 20-30 mmHg help reduce swelling and discomfort in people with lymphedema. These garments are generally well-tolerated, with most users not experiencing serious side effects. The gentle pressure moves fluid away from swollen areas, effectively easing symptoms.

Research also shows that manual lymphatic drainage (MLD), a specialized massage technique, improves the quality of life for those with lymphedema. MLD reduces swelling and improves symptoms without significant adverse effects. It involves gentle, rhythmic movements to encourage the flow of lymph fluid, part of the body's waste removal system.

Both treatments have a good safety profile based on existing research. No major safety concerns have been reported for either the compression garments or the manual lymphatic drainage techniques used in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing compression therapy and manual lymphatic drainage (MLD) for lymphedema because it explores new combinations and applications of existing treatments. Unlike standard treatment options that often rely on compression garments alone, this trial investigates the added benefit of MLD, a hands-on massage technique, alongside compression. This combination could offer a more effective approach to managing lymphedema by potentially speeding up the reduction of swelling and improving lymphatic function. The trial aims to determine whether integrating MLD with compression can yield better results than using compression alone, which could lead to enhanced treatment protocols for patients.

What evidence suggests that these treatment protocols could be effective for subclinical lymphedema?

This trial will compare the effectiveness of two treatments for lymphedema: wearing compression sleeves and gauntlets with a pressure of 20-30 mmHg, and Manual Lymphatic Drainage (MLD). Studies have shown that compression sleeves and gauntlets effectively reduce arm swelling in people with lymphedema by improving fluid movement, which decreases swelling. Research indicates that using these for four weeks may lead to significant improvements. Meanwhile, MLD, a special type of massage, also reduces swelling by enhancing lymph fluid flow. Studies have found that MLD can improve the quality of life for people with lymphedema. Both treatments have shown promising results in reducing swelling for lymphedema patients. Participants in this trial will be assigned to either the Compression Group or the Therapy Group, which includes both compression and MLD. ^{1 4 6 7 8}

Who Is on the Research Team?

Megan T Klote, DPT, CLT-LANA

Principal Investigator

Mercy Research

Are You a Good Fit for This Trial?

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

Able to provide informed consent

I am a woman aged 18 or older.

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

Exclusion Criteria

I have a recent deep vein blood clot.

Pregnancy

You have a pacemaker or other implanted electrical device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Pre-operative and periodic screenings for 3 years

Pre-operative, 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months

Treatment

Participants with abnormal L-dex scores receive either compression garments or compression plus Manual Lymphatic Drainage

Up to 4 weeks

Weekly L-dex assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years post-surgery

Periodic screenings as per surveillance schedule

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Manual lymphatic drainage (MLD) massage may help reduce the incidence of lymphedema in patients at-risk, particularly after breast cancer surgery, but results are mixed and more research is needed.

In cases of mild lymphedema, MLD can contribute to volume reduction, but it does not seem to offer additional benefits when used alongside complex decongestive therapy for moderate to severe lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual lymphatic drainage treatment for lymphedema: a systematic review of the literature. Thompson, B., Gaitatzis, K., Janse de Jonge, X., et al.[2021]

Compression therapy is effective in treating conditions like venous stasis and lymphedema by reducing limb swelling through methods such as limb elevation, compression pumps, and wraps.

Regular follow-up during maintenance therapy is crucial to ensure optimal treatment and to adjust care as needed, especially for patients with severe lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compression therapy for chronic venous insufficiency. Felty, CL., Rooke, TW.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03292198?cond=breast+cancer&aggFilters=status%3A

NCT03292198 | Subclinical Lymphedema Treatment Study 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02167659

NCT02167659 | Bioimpedance Spectroscopy Versus Tape ... study provided sound preliminary data to support that four weeks of treatment using a 20-30 mmHg compression garment and gauntlet can, over 18 months of post ...

3. withpower.com withpower.com/trial/compression-therapy-vs-manual-lymphatic-drainage-for-lymphedema-1816f

Compression Therapy vs Manual Lymphatic Drainage for ... Compression therapy is effective in treating conditions like venous stasis and lymphedema by reducing limb swelling through methods such as limb elevation, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10028125/

Prevention of lymphoedema after axillary clearance by ... Currently there is no large randomised trial evidence to support the value of compression garments in preventing lymphoedema after ANC. We ...

5. mediusa.com mediusa.com/conditions/lymphedema/breast-cancer-related/

Breast Cancer Related On average, 20-30% of patients are affected by breast cancer-related lymphedema following removal of the axillary lymph nodes.

6. cgsmedicare.com cgsmedicare.com/jb/pubs/news/2023/12/cope147943.html

Lymphedema Compression Treatment Items – Correct ... The right (RT) and left (LT) modifiers must be used with gradient compression garments, related supplies and accessories when laterality is indicated.

7. breastcancer.org breastcancer.org/treatment-side-effects/lymphedema/treatments/compression-sleeves

Compression Sleeves and Garments for Lymphedema Compression sleeves and garments for lymphedema can help reduce pain and swelling by moving accumulated fluids away from the affected area.

8. amazon.com amazon.com/Truform-Womens-Compression-Medical-Gauntlet/dp/B00FX7IX4A

Truform Lymphedema Compression Gauntlet, 20-30 ... Gentle graduated compression provides a massaging pressure gradient over inflamed tissue to help reduce swelling in the arms caused by a lymphatic system ...