Compression Therapy vs Manual Lymphatic Drainage for Lymphedema
(SLT Trial)
Trial Summary
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 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.12345
Is compression therapy and manual lymphatic drainage safe for humans?
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.611121314
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 scoresSecondary 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 scoresWomen 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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants with abnormal L-dex scores receive either compression garments or compression plus Manual Lymphatic Drainage
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 20-30 mmHg compression sleeve and gauntlet
- Manual Lymphatic Drainage
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mercy Research
Lead Sponsor
ImpediMed Limited
Industry Sponsor
Mercy Foundation
Collaborator
St. Louis Men's Group Against Cancer
Collaborator
Juzo USA
Collaborator