LymphedemaNCT03248310
A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
An observational study of Lymphedema, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial summary
This study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- Quality of Life Assessments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Aug 2017to Aug 2027
- Phase
- Observational
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients who present for consultation of their lymphedema and who meet eligibility criteria will be offered the option of enrolling in this study at the time of their initial consultation.
Who may be able to join
- Patients aged 18-80 years
- Primary and secondary lymphedema of the upper or lower extremity
- International Society of Lymphology (ISL) Stage 1, 2, or 3 lymphedema
- Proficiency in English language
Who cannot join
- Patients with clotting disorders, venous insufficiency, end-stage lymphedema unless they are on the non-surgical arm.
- Additionally, if the patient refuses to complete questionnaires, the patient will be excluded from the study and replaced at the discretion of the principal or co-principal investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Andrea Barrio, MD contact
United States3 sites, 3 recruiting
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Babak Mahrara, MD, 646-608-8085
Andrea Barrio, MD, 646-888-5118
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Babak Mahrara, MD, 646-608-8085
Andrea Barrio, MD, 646-888-5118
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
Babak Mahrara, PhD, 646-608-8085
About this study
Official title: A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
This study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery.
- Conditions
- Lymphedema
- Being tested
- Quality of Life Assessments
- Keywords
- Quality of Life (QoL), 17-377
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life AssessmentsBehavioural
Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.
| Study group | Role | What they receive |
|---|---|---|
| vascularized lymph node transfer (VLNT) | This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period. Receives: Behavioral: Quality of Life Assessments | |
| non-surgical treatment | This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period. Receives: Behavioral: Quality of Life Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Questionnaire to assess quality of life changes
Measured: up to 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start9 Aug 2017
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Babak Mahrara, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248310
- Sponsor's protocol ID
- 17-377
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2017
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
- ClinicalTrials.gov ID
- NCT03248310
- Acronym / sponsor ID
- 17-377
- Conditions
- Lymphedema
- Keywords
- Quality of Life (QoL), 17-377
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 14 Aug 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.
This study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vascularized lymph node transfer (VLNT) | – | Behavioral: Quality of Life AssessmentsThis is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period. |
| non-surgical treatment | – | Behavioral: Quality of Life AssessmentsThis is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who present for consultation of their lymphedema and who meet eligibility criteria will be offered the option of enrolling in this study at the time of their initial consultation.
Key inclusion criteria (4 listed)
- Patients aged 18-80 years
- Primary and secondary lymphedema of the upper or lower extremity
- International Society of Lymphology (ISL) Stage 1, 2, or 3 lymphedema
- Proficiency in English language
Key exclusion criteria (2 listed)
- Patients with clotting disorders, venous insufficiency, end-stage lymphedema unless they are on the non-surgical arm.
- Additionally, if the patient refuses to complete questionnaires, the patient will be excluded from the study and replaced at the discretion of the principal or co-principal investigator.
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 |
|---|---|---|
| Quality of Life AssessmentsUpper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg. | Behavioural | non-surgical treatment, vascularized lymph node transfer (VLNT) |
Primary outcome
Quality of Life
Time frame: up to 40 months
Questionnaire to assess quality of life changes
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 24 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Lymphedema
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Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
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A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
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Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
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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.
Andrea Barrio, MD contact
Babak Mahrara, MD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema, run by Memorial Sloan Kettering Cancer Center at 3 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 2 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 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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 Babak Mahrara, MD (646-608-8085, mehrarab@MSKCC.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: up to 40 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 24 Sep 2026.