LymphedemaNCT05056207
PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema
A study testing Cohort I (patients receiving annual lymphedema screening and Cohort II (patients followed intensively for lymphedema) in people with Lymphedema, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This research study is to learn about breast cancer patients' opinions about screening for lymphedema (a side effect of breast cancer treatment in which the arm can become heavy, painful, and/or swollen) and their satisfaction with the lymphedema screening program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema
- What is being tested?
- Cohort I (patients receiving annual lymphedema screening and Cohort II (patients followed intensively for lymphedema)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 17 Nov 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a Cohort A:
- Breast cancer patients with a baseline (preoperative perometer measurements) who have undergone axillary lymph node dissection
- English speaker
- Patients who participate in Cohort A will be eligible for enrollment in Cohort
- b Cohort I:
- Breast cancer patients who have undergone axillary lymph node dissection who have a clinic visit in the Nellie B. Connally Breast Center approximately 12 months (+/- 4 months) following axillary lymph node dissection
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- English speaker
- c Cohort II:
- Breast cancer patients who have undergone axillary lymph node dissection who are having a follow-up visit in the Nellie B. Connally Breast Center within 0-6 months following surgery who intend to continue follow-up care at MD Anderson
- English speaker
Who cannot join
- Inability to complete a self-administered questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
This research study is to learn about breast cancer patients' opinions about screening for lymphedema (a side effect of breast cancer treatment in which the arm can become heavy, painful, and/or swollen) and their satisfaction with the lymphedema screening program.
Read the detailed description
Primary Objectives:
- To determine the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer for reducing the cumulative incidence of grade lymphedema among breast cancer patients after ALND compared to routine screening. Secondary Objectives:
- To estimate the direct costs associated with the Lymphedema Screening Initiative
- To determine the association of the Initiative on patient productivity
- To determine patient satisfaction with the Lymphedema Initiative in the context of their cancer care
- To determine patient understanding of lymphedema-associated symptoms
- To determine patient self-reported compliance with treatments and measures to prevent lymphedema
- To determine the incidence of breast cancer-related lymphedema among a cohort of breast cancer patients treated with ALND To analyze clinical and pathological features associated with the development of lymphedema
- Conditions
- Lymphedema
- Being tested
- Cohort I (patients receiving annual lymphedema screening, Cohort II (patients followed intensively for lymphedema)
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort I (patients receiving annual lymphedema screeningOther
patientns who previously underwent preoperative perometer lymphedema screening
Cohort II (patients followed intensively for lymphedema)Other
patients who have recently undergone ALND
| Study group | Role | What they receive |
|---|---|---|
| Cohort I (patients receiving annual lymphedema screening) | Other | We will retrospectively retrieve information on patients who previously underwent preoperative perometer lymphedema screening during the past year who were treated definitively for their breast cancer with an ALND, and for whom no follow-up postoperative lymphedema screening was done. Receives: Other: Cohort I (patients receiving annual lymphedema screening |
| Cohort II (patients followed intensively for lymphedema) | Other | We will prospectively follow a cohort of 279 patients who have recently undergone ALND in this upcoming year with intensive lymphedema screening. Receives: Other: Cohort II (patients followed intensively for lymphedema) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start17 Nov 2017
- Primary completion17 Nov 2026 (estimated)
- Study completion17 Nov 2026 (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 M.D. Anderson 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simona Shaitelman, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056207
- Sponsor's protocol ID
- 2017-0639
- Other IDs
- NCI-2019-02478
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema
- ClinicalTrials.gov ID
- NCT05056207
- Acronym / sponsor ID
- 2017-0639
- Conditions
- Lymphedema
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 17 Nov 2026 (estimated)
- Study completion
- 17 Nov 2026 (estimated)
- First posted
- 24 Sep 2021 (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 research study is to learn about breast cancer patients' opinions about screening for lymphedema (a side effect of breast cancer treatment in which the arm can become heavy, painful, and/or swollen) and their satisfaction with the lymphedema screening program.
Detailed description
Primary Objectives:
- To determine the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer for reducing the cumulative incidence of grade lymphedema among breast cancer patients after ALND compared to routine screening. Secondary Objectives:
- To estimate the direct costs associated with the Lymphedema Screening Initiative
- To determine the association of the Initiative on patient productivity
- To determine patient satisfaction with the Lymphedema Initiative in the context of their cancer care
- To determine patient understanding of lymphedema-associated symptoms
- To determine patient self-reported compliance with treatments and measures to prevent lymphedema
- To determine the incidence of breast cancer-related lymphedema among a cohort of breast cancer patients treated with ALND To analyze clinical and pathological features associated with the development of lymphedema
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort I (patients receiving annual lymphedema screening) | Other | Other: Cohort I (patients receiving annual lymphedema screeningWe will retrospectively retrieve information on patients who previously underwent preoperative perometer lymphedema screening during the past year who were treated definitively for their breast cancer with an ALND, and for whom no follow-up postoperative lymphedema screening was done. |
| Cohort II (patients followed intensively for lymphedema) | Other | Other: Cohort II (patients followed intensively for lymphedema)We will prospectively follow a cohort of 279 patients who have recently undergone ALND in this upcoming year with intensive lymphedema screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Breast cancer patients with a baseline (preoperative perometer measurements) who have undergone axillary lymph node dissection
- English speaker
- Patients who participate in Cohort A will be eligible for enrollment in Cohort
- Breast cancer patients who have undergone axillary lymph node dissection who have a clinic visit in the Nellie B. Connally Breast Center approximately 12 months (+/- 4 months) following axillary lymph node dissection
- English speaker
Key exclusion criteria (1 listed)
- Inability to complete a self-administered questionnaire
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 |
|---|---|---|
| Cohort I (patients receiving annual lymphedema screeningpatientns who previously underwent preoperative perometer lymphedema screening | Other | Cohort I (patients receiving annual lymphedema screening) |
| Cohort II (patients followed intensively for lymphedema)patients who have recently undergone ALND | Other | Cohort II (patients followed intensively for lymphedema) |
Primary outcome
To establish the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer.
Time frame: through study completion, an average of 1 year
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 14 Sep 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Simona Shaitelman principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cohort I (patients receiving annual lymphedema screening and Cohort II (patients followed intensively for lymphedema) in people with Lymphedema, run by M.D. Anderson Cancer Center 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 10 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 14 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 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?
To establish the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer. (time frame: through study completion, an average of 1 year). 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 14 Sep 2026.