LymphedemaNCT03428581
Preventing Lymphedema in Axillary Lymph Node Dissection
A study testing ALND with ARM +/- LVB and ALND in people with Lymphedema and Breast Cancer, run by Mayo Clinic at 2 sites in United States.
Trial summary
The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema, Breast Cancer, Melanoma
- What is being tested?
- ALND with ARM +/- LVB and ALND
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Apr 2018to 11 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients scheduled to undergo an axillary lymph node dissection
- Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings
- English speaking
Who cannot join
- Prior ipsilateral axillary lymph node dissection
- Prior ipsilateral axillary radiation
- Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement
- Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema.
- Pregnant patients cannot participate in the substudy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Preventing Lymphedema in Patients Undergoing Axillary Lymph Node Dissection Via Axillary Reverse Mapping and Lympho-venous Bypass
The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.
Read the detailed description
All subjects will undergo an axillary lymph node dissection (ALND). Cluster randomization will determine which of these subjects will have the ARM with LVB and which subjects will have the ALND without this technique. As a baseline, all subjects will have the circumference of their arms measured and complete a questionnaire about lymphedema. Performing the measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after surgery.
- Conditions
- Lymphedema, Breast Cancer, Melanoma
- Being tested
- ALND with ARM +/- LVB, ALND
- Keywords
- Axillary, Lymph node, Dissection, Reverse Mapping, Lympho-venous Bypass (LVB), Axillary Reverse Mapping (ARM)
- Medical subject headings
- Lymphedema, Breast Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALND with ARM +/- LVBProcedure or surgery
Subjects will undergo removal of the lymph nodes in the underarm or "axilla" area. This is referred to as an axillary lymph node dissection (ALND). The procedure for identifying the drainage of the arm lymphatics during an axillary dissection has been coined axillary reverse mapping (ARM). Lympho-venous bypass (LVB) is a technique incorporated along with the ARM procedure that allows preservation of the lymphatics draining the arm while removing the standard lymph nodes and not compromising the extent of the axillary dissection.
ALNDProcedure or surgery
Prospective and retrospective subjects undergoing an ALND.
| Study group | Role | What they receive |
|---|---|---|
| ALND with ARM +/- LVB | Experimental | Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed. Receives: Procedure: ALND with ARM +/- LVB |
| ALND without ARM +/- LVB | Active comparator | Axillary Lymph Node Dissection (ALND) Receives: Procedure: ALND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity
Bilateral Limb volume measurements
Measured: 36 months following surgery
Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity
Validated patient reported surveys
Measured: 36 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start10 Apr 2018
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Why it stopped: slow accrual; diminished funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James W. Jakub, Mayo Clinic
- Investigators
- James W Jakub, MD, Principal investigator, Mayo ClinicMara A. Piltin, DO, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428581
- Sponsor's protocol ID
- 16-010491
- Other IDs
- NCI-2022-11065
- Status last verified
- Jan 2026
- First submitted
- 23 Oct 2017
- Last updated
- 24 Feb 2026
- 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 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Lymphedema in Patients Undergoing Axillary Lymph Node Dissection Via Axillary Reverse Mapping and Lympho-venous Bypass
- ClinicalTrials.gov ID
- NCT03428581
- Acronym / sponsor ID
- 16-010491
- Conditions
- Lymphedema, Breast Cancer, Melanoma
- Keywords
- Axillary, Lymph node, Dissection, Reverse Mapping, Lympho-venous Bypass (LVB), Axillary Reverse Mapping (ARM)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual; diminished funding
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 9 Feb 2018 (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.
The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.
Detailed description
All subjects will undergo an axillary lymph node dissection (ALND). Cluster randomization will determine which of these subjects will have the ARM with LVB and which subjects will have the ALND without this technique. As a baseline, all subjects will have the circumference of their arms measured and complete a questionnaire about lymphedema. Performing the measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALND with ARM +/- LVB | Experimental | Procedure: ALND with ARM +/- LVBAxillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed. |
| ALND without ARM +/- LVB | Active comparator | Procedure: ALNDAxillary Lymph Node Dissection (ALND) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled to undergo an axillary lymph node dissection
- Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings
- English speaking
Key exclusion criteria (5 listed)
- Prior ipsilateral axillary lymph node dissection
- Prior ipsilateral axillary radiation
- Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement
- Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema.
- Pregnant patients cannot participate in the substudy
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 |
|---|---|---|
| ALND with ARM +/- LVBSubjects will undergo removal of the lymph nodes in the underarm or "axilla" area. This is referred to as an axillary lymph node dissection (ALND). The procedure for identifying the drainage of the arm lymphatics during an axillary dissection has been coined axillary reverse mapping (ARM). Lympho-venous bypass (LVB) is a technique incorporated along with the ARM procedure that allows preservation of the lymphatics draining the arm while removing the standard lymph nodes and not compromising the extent of the axillary dissection. | Procedure or surgery | ALND with ARM +/- LVB |
| ALNDProspective and retrospective subjects undergoing an ALND. | Procedure or surgery | ALND without ARM +/- LVB |
Primary outcome
Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity
Time frame: 36 months following surgery
Bilateral Limb volume measurements
Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity
Time frame: 36 months following surgery
Validated patient reported surveys
Results and safety
The study was stopped early (reason given: slow accrual; diminished funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
James W Jakub, MD principal investigator
Mayo Clinic
Mara A. Piltin, DO principal investigator
Mayo Clinic in Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALND with ARM +/- LVB and ALND in people with Lymphedema and Breast Cancer, run by Mayo Clinic at 2 sites 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: slow accrual; diminished funding). Results are not available in the source record.
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?
Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity (time frame: 36 months following surgery). The study lists 2 primary outcomes in all. 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 24 Feb 2026.