Compression Therapy vs Manual Lymphatic Drainage for Lymphedema

(SLT Trial)

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

267 Participants Needed

What You Need to Know Before You Apply

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.

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.

Is compression therapy and manual lymphatic drainage safe for humans?

Compression therapy and manual lymphatic drainage are generally considered safe for humans, as they have been used for many years to treat conditions like lymphedema and venous issues. However, it's important to have periodic follow-ups during treatment to ensure safety and effectiveness. ^{1 2 3 4 5}

How does the treatment of compression therapy and manual lymphatic drainage for lymphedema differ from other treatments?

This treatment combines a compression sleeve and gauntlet with manual lymphatic drainage (a special type of massage) to help reduce swelling in lymphedema. Unlike other treatments, it uses both compression and massage to stimulate fluid movement and open new drainage pathways, which can be more effective than using compression alone. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment for lymphedema?

While the research does not directly address lymphedema, studies on manual therapy for shoulder conditions suggest it can improve mobility and reduce pain. This indicates that manual lymphatic drainage, a type of manual therapy, might also help with lymphedema by improving fluid movement and reducing discomfort. ^{10 11 12 13 14}

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

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

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

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of manual physical therapy for painful shoulder conditions: a systematic review. [2021]

2. Pakistan pubmed.ncbi.nlm.nih.gov

Comparison between Manual Traction, Manual Opening technique and Combination in Patients with cervical radiculopathy: Randomized Control Trial. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Effectiveness of Dry Needling in Subacromial Syndrome. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Shoulder functionality after manual therapy in subjects with shoulder impingement syndrome: a case series. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Monitoring, implementation and reporting of interventions in a selection of trials assessing exercise therapy for the management of shoulder subacromial pain: a cross-sectional investigation. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Compression therapy for chronic venous insufficiency. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of compression bandaging with or without manual lymph drainage treatment in patients with postoperative arm lymphedema. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Manual lymph drainage when added to advice and exercise may not be effective in preventing lymphoedema after surgery for breast cancer. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Evidence-based or traditional treatment of cancer-related lymphedema. [2015]

10. Czech Republic pubmed.ncbi.nlm.nih.gov

Effect of manual lymphatic drainage on upper limb lymphedema after surgery for breast cancer. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Manual lymphatic drainage treatment for lymphedema: a systematic review of the literature. [2021]

12. China pubmed.ncbi.nlm.nih.gov

[Treatment of chronic extremity lymphedema with manual lymph drainage]. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

The addition of manual lymph drainage to compression therapy for breast cancer related lymphedema: a randomized controlled trial. [2022]

14. France pubmed.ncbi.nlm.nih.gov

[Lymphoscintigraphic aspects of the effects of manual lymphatic drainage]. [2016]