LymphedemaPhase 3NCT06144164
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
A Phase 3 study testing Immediate Lymphatic Reconstruction, Volumetric arm measurements and Lymphatic massage in people with Lymphedema and Lymphedema Arm, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm
- What is being tested?
- Immediate Lymphatic Reconstruction, Volumetric arm measurements and Lymphatic massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Nov 2023to 16 Mar 2030
- Phase
- Phase 3
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex
- Diagnosis of breast cancer
- Ages 18 to 75 years
- Consented for unilateral ALND or for unilateral SLNB with possible ALND
Who cannot join
- Male sex
- Does not speak English
- Does not fit into study garment
- Axillary recurrence
- History of ALND
- Requirement of bilateral ALND for the treatment of breast cancer
Show all 9Show fewer
- Treatment with SLNB only
- Known anaphylactic allergy to ICG dye used in ILR
- Impaired decision-making capacity
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Michelle Coriddi, MD, 646-608-8042
- Recruiting
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725
Michelle Coriddi, MD, 646-608-8042
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Michelle Coriddi, MD, 646-608-8042
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Michelle Coriddi, MD, 646-608-8042
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Michelle Coriddi, MD, 646-608-8042
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Michelle Coriddi, MD, 646-608-8042
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Michelle Coriddi, MD, 646-608-8042
About this study
Official title: A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life
The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.
- Conditions
- Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Breast Cancer, Breast Carcinoma, Female Breast Cancer
- Being tested
- Immediate Lymphatic Reconstruction, Volumetric arm measurements, Lymphatic massage, Range of motion exercises, Compression garment use
- Keywords
- immediate lymphatic reconstruction, axillary lymph node dissection, Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Breast cancer, breast carcinoma, female breast cancer, Memorial Sloan Kettering Cancer Center, 23-303
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Lymphatic ReconstructionProcedure or surgery
Also called ILR
Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection
Volumetric arm measurementsDiagnostic test
Volumetric arm measurements will occur at each in-person postoperative visit time points.
Lymphatic massageOther
Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed
Range of motion exercisesOther
Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed
Compression garment useOther
Participants will use compression garments 24 to 48 h after surgery and will continue daily use for at least 8 h a day for 3 months or until 3 months after any adjuvant treatments are completed
| Study group | Role | What they receive |
|---|---|---|
| Participants with Breast Cancer | Experimental | Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection. Receives: Procedure: Immediate Lymphatic Reconstruction; Diagnostic Test: Volumetric arm measurements; Other: Lymphatic massage; Other: Range of motion exercises; Other: Compression garment use |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the baseline and postoperative arm volume measurement
The primary objective is to determine the efficacy of a prevention program in decreasing the development of lymphedema in participants treated for breast cancer with Axillary Lymph Node Dissection/ALND by use of arm volume measurements. A ≥ 10% increase in RVC (arm volume difference between the affected and unaffected arms) between baseline and postoperative measures occurring at 12 months or later will indicate the development of lymphedema
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start16 Nov 2023
- Primary completion16 Mar 2030 (estimated)
- Study completion16 Mar 2030 (estimated)
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 Memorial Sloan Kettering Cancer CenterThe 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Coriddi, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144164
- Sponsor's protocol ID
- 23-303
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2023
- Last updated
- 10 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life
- ClinicalTrials.gov ID
- NCT06144164
- Acronym / sponsor ID
- 23-303
- Conditions
- Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Breast Cancer, Breast Carcinoma, Female Breast Cancer
- Keywords
- immediate lymphatic reconstruction, axillary lymph node dissection, Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Breast cancer, breast carcinoma, female breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 16 Mar 2030 (estimated)
- Study completion
- 16 Mar 2030 (estimated)
- First posted
- 22 Nov 2023 (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 purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Breast Cancer | Experimental | Procedure: Immediate Lymphatic Reconstruction, Diagnostic Test: Volumetric arm measurements, Other: Lymphatic massage, Other: Range of motion exercises, Other: Compression garment useParticipants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female sex
- Diagnosis of breast cancer
- Ages 18 to 75 years
- Consented for unilateral ALND or for unilateral SLNB with possible ALND
Key exclusion criteria (9 listed)
- Male sex
- Does not speak English
- Does not fit into study garment
- Axillary recurrence
- History of ALND
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 |
|---|---|---|
| Immediate Lymphatic ReconstructionAlso: ILRImmediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection | Procedure or surgery | Participants with Breast Cancer |
| Volumetric arm measurementsVolumetric arm measurements will occur at each in-person postoperative visit time points. | Diagnostic test | Participants with Breast Cancer |
| Lymphatic massageParticipants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed | Other | Participants with Breast Cancer |
| Range of motion exercisesParticipants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed | Other | Participants with Breast Cancer |
| Compression garment useParticipants will use compression garments 24 to 48 h after surgery and will continue daily use for at least 8 h a day for 3 months or until 3 months after any adjuvant treatments are completed | Other | Participants with Breast Cancer |
Primary outcome
The difference between the baseline and postoperative arm volume measurement
Time frame: Up to 24 months
The primary objective is to determine the efficacy of a prevention program in decreasing the development of lymphedema in participants treated for breast cancer with Axillary Lymph Node Dissection/ALND by use of arm volume measurements. A ≥ 10% increase in RVC (arm volume difference between the affected and unaffected arms) between baseline and postoperative measures occurring at 12 months or later will indicate the development of lymphedema
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 10 Nov 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Michelle Coriddi, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immediate Lymphatic Reconstruction, Volumetric arm measurements and Lymphatic massage in people with Lymphedema and Lymphedema Arm, run by Memorial Sloan Kettering Cancer Center at 7 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Michelle Coriddi, MD (646-608-8042, coriddim@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between the baseline and postoperative arm volume measurement (time frame: Up to 24 months). 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 10 Nov 2025.