Breast Cancer-related Subclinical LymphedemaSLTNCT03292198
Subclinical Lymphedema Treatment Study
A study testing 20-30 mmHg compression sleeve and gauntlet and Manual Lymphatic Drainage in people with Breast Cancer-related Subclinical Lymphedema, run by Mercy Research at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer-related Subclinical Lymphedema
- What is being tested?
- 20-30 mmHg compression sleeve and gauntlet and Manual Lymphatic Drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New diagnosis of breast cancer, Female, 18 years of age or older, Upcoming unilateral axillary lymph node procedure (biopsy or dissection), Able to provide informed consent
Who cannot join
- Pre-existing diagnosis of lymphedema, as diagnosed by physician, History of axillary lymph node procedure, including biopsy, dissection, or radiation to, Pregnancy, Pacemaker or other implanted electrical device, Stage 4-5 kidney disease, Severe liver disease, Active infection, Acute Deep Vein Thrombosis, Unmanaged congestive heart failure or a cardiac event in the past 6 months, Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Mercy David C. Pratt Cancer Center
St Louis, Missouri, 63141
About this study
Official title: Treatment Indications for Breast Cancer-related Subclinical Lymphedema Identified Through a Bioimpedance Surveillance Model
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
Read more
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.
Read the detailed description
Lymphedema is an accumulation of fluid in the interstitial tissues resulting from an impairment of the normal lymphatic drainage of the affected region. Lymphedema is often a side effect of breast cancer treatments such as axillary lymph node surgery and radiation, as these procedures are damaging to the lymphatic structures. Due to poor awareness of the condition, minimal education is given to patients about their risk for lymphedema as a result of cancer treatments. With inconsistent diagnostic methods, many cases of breast cancer-related lymphedema are diagnosed after the condition has progressed to its irreversible and chronic form, i.e. clinical lymphedema.
Bioimpedance spectroscopy (BIS) uses a low frequency electrical current to assess extracellular fluid of the limbs. BIS has proven to be a sensitive and specific tool for detecting subclinical lymphedema (Stage 0) and has been validated in its use within a surveillance model. Recent literature supports the use of a surveillance model to identify breast cancer-related subclinical lymphedema to allow for early intervention and improved patient outcomes.
Despite the growing body of evidence supporting the importance of early identification of lymphedema in the subclinical stage, there is limited evidence to guide treatment of this patient population. Treatment parameters for subclinical lymphedema stem primarily from a study by Stout et al. indicating that a short compression trial (mean duration of 4.4 weeks) of 20-30 mmHg garments effectively treated subclinical lymphedema identified by perometry by preventing progression to late-stage lymphedema.
Surveillance of arm volume will be performed using bioimpedance spectroscopy (BIS) testing with the Impedimed® L-dex U400. Subjects will receive BIS testing (1) pre-operatively, (2) post-operatively at 6 weeks, (3) 3 months, (4) 6 months, (5) 12 months, (6) 18 months, (7) 24 months, and (8) 36 months. The outcome measure will be the L-dex score.
Only subjects who have an abnormal result will be enrolled in the experimental portion of the study. If an L-dex score is abnormal (defined by a change of +7 units from her pre-operative baseline), the subject is determined to exhibit subclinical lymphedema. As a result, these subjects will be randomized into one of two intervention groups. The group receiving only compression intervention will be referred to as the compression group (CG). The group receiving Manual Lymphatic Drainage (MLD) and compression will be referred to as the therapy group (TG).
Subjects will be followed through screenings for a maximum of 3 years post-surgically.
The investigators hope that this study will take the next step in the surveillance model by answering questions about how patients with subclinical lymphedema should be clinically managed.
- Being tested
- 20-30 mmHg compression sleeve and gauntlet, Manual Lymphatic Drainage
- Keywords
- Subclinical lymphedema, bioimpedance, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-30 mmHg compression sleeve and gauntletOther
Compression garments are Juzo Soft, circular knit. Most will be off-the-shelf sizing, but custom when necessary.
Garment fittings will be performed by Certified Lymphedema Therapists.
Manual Lymphatic DrainageOther
Also called MLD
Manual Lymphatic Drainage (MLD) is a gentle skin-stretch massage that stimulates the lymphatic system and assists in creating collateral drainage pathways out of non-intact (damaged) lymphatic territories. MLD is a critical part of Complete Decongestive Therapy (CDT), which is accepted as the international standard of care in the treatment of lymphedema.
The MLD sessions will be performed by 2 Certified Lymphedema Therapists, Megan Klote and Sarah Stolker, both trained through the Norton School of Lymphatic Therapy. The therapists have completed reliability meetings regarding MLD sequencing and techniques.
| Study group | Role | What they receive |
|---|---|---|
| Compression Group | Active comparator | 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. Receives: Other: 20-30 mmHg compression sleeve and gauntlet |
| Therapy Group | Experimental | 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. Receives: Other: 20-30 mmHg compression sleeve and gauntlet; Other: Manual Lymphatic Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
L-dex scores
Measured: 3 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Apr 2018
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer-related Subclinical LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Research
- Sponsor type
- University, hospital or other
- Collaborators
- ImpediMed Limited
- Responsible party
- Principal investigator, Megan Klote, Mercy Research
- Investigators
- Megan T Klote, DPT, CLT-LANA, Principal investigator, Mercy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292198
- Sponsor's protocol ID
- 1070741-1
- Acronym
- SLT
- Status last verified
- Feb 2025
- First submitted
- 21 Sep 2017
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Indications for Breast Cancer-related Subclinical Lymphedema Identified Through a Bioimpedance Surveillance Model
- ClinicalTrials.gov ID
- NCT03292198
- Acronym / sponsor ID
- SLT / 1070741-1
- Keywords
- Subclinical lymphedema, bioimpedance, breast cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Mercy ResearchUniversity, hospital or other
- Collaborators
- ImpediMed Limited
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lymphedema is an accumulation of fluid in the interstitial tissues resulting from an impairment of the normal lymphatic drainage of the affected region. Lymphedema is often a side effect of breast cancer treatments such as axillary lymph node surgery and radiation, as these procedures are damaging to the lymphatic structures. Due to poor awareness of the condition, minimal education is given to patients about their risk for lymphedema as a result of cancer treatments. With inconsistent diagnostic methods, many cases of breast cancer-related lymphedema are diagnosed after the condition has progressed to its irreversible and chronic form, i.e. clinical lymphedema.
Bioimpedance spectroscopy (BIS) uses a low frequency electrical current to assess extracellular fluid of the limbs. BIS has proven to be a sensitive and specific tool for detecting subclinical lymphedema (Stage 0) and has been validated in its use within a surveillance model. Recent literature supports the use of a surveillance model to identify breast cancer-related subclinical lymphedema to allow for early intervention and improved patient outcomes.
Despite the growing body of evidence supporting the importance of early identification of lymphedema in the subclinical stage, there is limited evidence to guide treatment of this patient population. Treatment parameters for subclinical lymphedema stem primarily from a study by Stout et al. indicating that a short compression trial (mean duration of 4.4 weeks) of 20-30 mmHg garments effectively treated subclinical lymphedema identified by perometry by preventing progression to late-stage lymphedema.
Surveillance of arm volume will be performed using bioimpedance spectroscopy (BIS) testing with the Impedimed® L-dex U400. Subjects will receive BIS testing (1) pre-operatively, (2) post-operatively at 6 weeks, (3) 3 months, (4) 6 months, (5) 12 months, (6) 18 months, (7) 24 months, and (8) 36 months. The outcome measure will be the L-dex score.
Only subjects who have an abnormal result will be enrolled in the experimental portion of the study. If an L-dex score is abnormal (defined by a change of +7 units from her pre-operative baseline), the subject is determined to exhibit subclinical lymphedema. As a result, these subjects will be randomized into one of two intervention groups. The group receiving only compression intervention will be referred to as the compression group (CG). The group receiving Manual Lymphatic Drainage (MLD) and compression will be referred to as the therapy group (TG).
Subjects will be followed through screenings for a maximum of 3 years post-surgically.
The investigators hope that this study will take the next step in the surveillance model by answering questions about how patients with subclinical lymphedema should be clinically managed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compression Group | Active comparator | Other: 20-30 mmHg compression sleeve and gauntletSubjects 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. |
| Therapy Group | Experimental | Other: 20-30 mmHg compression sleeve and gauntlet, Other: Manual Lymphatic DrainageSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New diagnosis of breast cancer, Female, 18 years of age or older, Upcoming unilateral axillary lymph node procedure (biopsy or dissection), Able to provide informed consent
Key exclusion criteria (1 listed)
- Pre-existing diagnosis of lymphedema, as diagnosed by physician, History of axillary lymph node procedure, including biopsy, dissection, or radiation to, Pregnancy, Pacemaker or other implanted electrical device, Stage 4-5 kidney disease, Severe liver disease, Active infection, Acute Deep Vein Thrombosis, Unmanaged congestive heart failure or a cardiac event in the past 6 months, Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20-30 mmHg compression sleeve and gauntletCompression garments are Juzo Soft, circular knit. Most will be off-the-shelf sizing, but custom when necessary. Garment fittings will be performed by Certified Lymphedema Therapists. | Other | Compression Group, Therapy Group |
| Manual Lymphatic DrainageAlso: MLDManual Lymphatic Drainage (MLD) is a gentle skin-stretch massage that stimulates the lymphatic system and assists in creating collateral drainage pathways out of non-intact (damaged) lymphatic territories. MLD is a critical part of Complete Decongestive Therapy (CDT), which is accepted as the international standard of care in the treatment of lymphedema. The MLD sessions will be performed by 2 Certified Lymphedema Therapists, Megan Klote and Sarah Stolker, both trained through the Norton School of Lymphatic Therapy. The therapists have completed reliability meetings regarding MLD sequencing and techniques. | Other | Therapy Group |
Primary outcome
L-dex scores
Time frame: 3 years post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan T Klote, DPT, CLT-LANA principal investigator
Mercy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20-30 mmHg compression sleeve and gauntlet and Manual Lymphatic Drainage in people with Breast Cancer-related Subclinical Lymphedema, run by Mercy Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
L-dex scores (time frame: 3 years post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.