LymphedemaNCT05929001
Lymphedema Specific PROs for Risk Assessment, Prevention and Early Detection
An observational study of Lymphedema, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to find a way to detect a surgical complication, called lymphedema, at an earlier stage. This potential complication may develop in some patients after removal of the armpit lymph nodes (axillary dissection). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2021to 15 Apr 2026
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients who are scheduled for or who just had axillary dissection at the University of Miami.
Who may be able to join
- Patients 18 years old and older with biopsy-proven breast cancer.
- Scheduled for axillary dissection or probable axillary dissection or within 14 days after axillary dissection at either Jackson Memorial Hospital (JMH) or University of Miami (UM).
- Patients that eventually did not undergo full axillary dissection but had 9 or more lymph nodes removed or received axillary radiation will be allowed to stay in the study.
- Intent to continue follow-up for at least 6 months post-operatively.
- Able to give an informed consent to participate in all study's stages.
- Willing and able to fill questionnaires in person or with assistance at baseline and at 6 months from surgery.
- Bilateral axillary dissection patients are eligible to be enrolled for each side.
Who cannot join
- Previous axillary dissection.
- Lymph node biopsy except for biopsies related to the current cancer event.
- Congenital or acquired arm lymphedema.
- Nephrotic Syndrome
- Anasarca
- Unable or unwilling to fill questionnaires at baseline and at 6 months from surgery.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to find a way to detect a surgical complication, called lymphedema, at an earlier stage. This potential complication may develop in some patients after removal of the armpit lymph nodes (axillary dissection). It is very important to identify this condition as early as possible to improve the treatment options. This study will examine whether or not focused questionnaires are able to identify lymphedema, comparing to physical measurements (like arm circumference).
- Conditions
- Lymphedema
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lymphedema Risk Group | Participants in this group will: 1. Completed questionnaires about daily function and mood, 2. Undergo arm circumference measurement conducted by medical staff, and 3. Undergo Lymphedema Index Test (L-DEX) or measurement of tissue water content, conducted standard of care. Total expected participation is about six months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4) PRO Scores
Patient reported outcomes (PROs) are a measure of health-related quality of life. The Functional Assessment of Cancer Therapy-Breast (FACT-B+4) will be administered to participants to measure the change in the quality of life after axillary dissection. The FACT-B+4 is a 41-item questionnaire designed to measure six domains of health-related QOL in breast cancer patients: Physical, social, emotional, functional well-being, breast-cancer subscale (BCS) as well as lymphedema subscale. Each response within each domain is scored on a five-point Likert scale ranging from "0" (not at all) to 5 (very much). Higher scores indicate a better quality of life.
Measured: Baseline (pre-operative), postoperative, up to 6 months
Change in Lymphoedema Functioning, Disability and Health Questionnaire (Lymph-ICF) PRO Scores
Patient reported outcomes (PROs) are a measure of health-related quality of life. The Lymphoedema Functioning, Disability and Health Questionnaire (Lymph-ICF) will be administered to participants to measure the change in quality of life after axillary dissection. The Lymph ICF is a 29-item questionnaire about impairments in function, activity limitations, and participation restrictions of patients with breast cancer and arm lymphedema. The questionnaire is divided into 5 domains: Physical function, mental function, household activities, mobility activities, and life and social activities. Each response within each domain is scored on a 11-point Likert scale ranging from "0" (not at all) to "10" (a lot). Lower scores indicate a better quality of life.
Measured: Baseline (pre-operative), postoperative, up to 6 months
Change in Quality of Life Measure for Limb Lymphoedema (LYMQOL) Scores
The LYMQOL-Arm, primarily as a self-assessment report questionnaire assessing the symptoms of lymphedema in the upper extremity and the ability to perform functional activities in patients with breast cancer-associated lymphedema. There are five subsections in the 21-question survey. These are upper extremity function (questions 1a-h,2,3), appearance (questions 4-8), symptoms (questions 9-14), emotional state (questions 15-20), and general quality of life ( 21st question). In the first 20 questions, there are four options for each question: none (1 point), a little (2 points), quite (3 points), and a lot (4 points). The scores of these subsections are summed up within themselves and divided by the number of questions answered. In the 21st question, the patient is asked to give a value between 0 and 10 for the quality of life. High scores for the first 20 questions and low scores for the 21st question indicate poor quality of life.
Measured: Baseline (pre-operative), up to 6 months
Change in Lymphedema rate as measured by L-DEX Test
Lymphedema rate among study participants as measured by the Lymphedema Index Test (L-DEX) and by arm circumference. Lymphedema rate will be reported as the number of participants diagnosed with lymphedema after axillary dissection or radiation. The L-DEX test is a bioimpedance spectroscopy measurement of tissue water content and compares the fluid in a limb at-risk for lymphedema to a healthy limb in order to detect lymphedema.
Measured: Baseline, Up to 6 months
Secondary outcomes (2)
Breast Cancer-Related Lymphedema (BCRL) Status: Odds Ratio
Breast Cancer-Related Lymphedema (BCRL) status among study participants as measured by odds ratio.
Measured: Up to 6 months
Breast Cancer-Related Lymphedema (BCRL) Status: Area Under the Receiver Operating Characteristic Curve (AUROC)
Breast Cancer-Related Lymphedema (BCRL) status among study participants as measured by Area Under the Receiver Operating Characteristic Curve (AUROC)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start13 Jan 2021
- Primary completion31 Dec 2024
- Study completion15 Apr 2026
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 University of MiamiThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eli Avisar, MD, University of Miami
- Investigators
- Eli Avisar, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929001
- Sponsor's protocol ID
- 20201038
- Other IDs
- NCI-2021-01490
- Status last verified
- Apr 2026
- First submitted
- 25 Jun 2023
- Last updated
- 17 Apr 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphedema Specific PROs for Risk Assessment, Prevention and Early Detection
- ClinicalTrials.gov ID
- NCT05929001
- Acronym / sponsor ID
- 20201038
- Conditions
- Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 3 Jul 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 is to find a way to detect a surgical complication, called lymphedema, at an earlier stage. This potential complication may develop in some patients after removal of the armpit lymph nodes (axillary dissection). It is very important to identify this condition as early as possible to improve the treatment options. This study will examine whether or not focused questionnaires are able to identify lymphedema, comparing to physical measurements (like arm circumference).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphedema Risk Group | – | –Participants in this group will: 1. Completed questionnaires about daily function and mood, 2. Undergo arm circumference measurement conducted by medical staff, and 3. Undergo Lymphedema Index Test (L-DEX) or measurement of tissue water content, conducted standard of care. Total expected participation is about six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients who are scheduled for or who just had axillary dissection at the University of Miami.
Key inclusion criteria (7 listed)
- Patients 18 years old and older with biopsy-proven breast cancer.
- Scheduled for axillary dissection or probable axillary dissection or within 14 days after axillary dissection at either Jackson Memorial Hospital (JMH) or University of Miami (UM).
- Patients that eventually did not undergo full axillary dissection but had 9 or more lymph nodes removed or received axillary radiation will be allowed to stay in the study.
- Intent to continue follow-up for at least 6 months post-operatively.
- Able to give an informed consent to participate in all study's stages.
Key exclusion criteria (6 listed)
- Previous axillary dissection.
- Lymph node biopsy except for biopsies related to the current cancer event.
- Congenital or acquired arm lymphedema.
- Nephrotic Syndrome
- Anasarca
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4) PRO Scores
Time frame: Baseline (pre-operative), postoperative, up to 6 months
Patient reported outcomes (PROs) are a measure of health-related quality of life. The Functional Assessment of Cancer Therapy-Breast (FACT-B+4) will be administered to participants to measure the change in the quality of life after axillary dissection. The FACT-B+4 is a 41-item questionnaire designed to measure six domains of health-related QOL in breast cancer patients: Physical, social, emotional, functional well-being, breast-cancer subscale (BCS) as well as lymphedema subscale. Each response within each domain is scored on a five-point Likert scale ranging from "0" (not at all) to 5 (very much). Higher scores indicate a better quality of life.
Change in Lymphoedema Functioning, Disability and Health Questionnaire (Lymph-ICF) PRO Scores
Time frame: Baseline (pre-operative), postoperative, up to 6 months
Patient reported outcomes (PROs) are a measure of health-related quality of life. The Lymphoedema Functioning, Disability and Health Questionnaire (Lymph-ICF) will be administered to participants to measure the change in quality of life after axillary dissection. The Lymph ICF is a 29-item questionnaire about impairments in function, activity limitations, and participation restrictions of patients with breast cancer and arm lymphedema. The questionnaire is divided into 5 domains: Physical function, mental function, household activities, mobility activities, and life and social activities. Each response within each domain is scored on a 11-point Likert scale ranging from "0" (not at all) to "10" (a lot). Lower scores indicate a better quality of life.
Change in Quality of Life Measure for Limb Lymphoedema (LYMQOL) Scores
Time frame: Baseline (pre-operative), up to 6 months
The LYMQOL-Arm, primarily as a self-assessment report questionnaire assessing the symptoms of lymphedema in the upper extremity and the ability to perform functional activities in patients with breast cancer-associated lymphedema. There are five subsections in the 21-question survey. These are upper extremity function (questions 1a-h,2,3), appearance (questions 4-8), symptoms (questions 9-14), emotional state (questions 15-20), and general quality of life ( 21st question). In the first 20 questions, there are four options for each question: none (1 point), a little (2 points), quite (3 points), and a lot (4 points). The scores of these subsections are summed up within themselves and divided by the number of questions answered. In the 21st question, the patient is asked to give a value between 0 and 10 for the quality of life. High scores for the first 20 questions and low scores for the 21st question indicate poor quality of life.
Change in Lymphedema rate as measured by L-DEX Test
Time frame: Baseline, Up to 6 months
Lymphedema rate among study participants as measured by the Lymphedema Index Test (L-DEX) and by arm circumference. Lymphedema rate will be reported as the number of participants diagnosed with lymphedema after axillary dissection or radiation. The L-DEX test is a bioimpedance spectroscopy measurement of tissue water content and compares the fluid in a limb at-risk for lymphedema to a healthy limb in order to detect lymphedema.
2 secondary outcomes
Breast Cancer-Related Lymphedema (BCRL) Status: Odds Ratio
Time frame: Up to 6 months
Breast Cancer-Related Lymphedema (BCRL) Status: Area Under the Receiver Operating Characteristic Curve (AUROC)
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
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
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
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Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
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The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
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.
Eli Avisar, MD principal investigator
University of Miami
1 site 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 University of Miami 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 17 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4) PRO Scores (time frame: Baseline (pre-operative), postoperative, up to 6 months). The study lists 4 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 17 Apr 2026.