LymphedemaNCT07855627
Prediction Of Lymphedema In Patients With Inflammatory BreastCancer Using Preoperative Bioimpedance Measurements
An observational study of Lymphedema and Inflammatory Breast Cancer (IBC), run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To find out whether the BIA test can help identify participants with IBC who are at risk for developing lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema, Inflammatory Breast Cancer (IBC), Preoperative
- What is being tested?
- Neoadjuvant therapy
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2026to 31 Dec 2029
- Phase
- Observational
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
Study population: UT MD Anderson Cancer Center
Eligibility Criteria All women≥18 years old with newly diagnosed inflammatory breast cancer without prior breast/axillary surgery who are eligible for standard of care (NST, MRM, and radiation therapy).
Exclusion Criteria Prior breast/axillary surgery. Participants with pacemakers or other implanted electronic medical devices. Participants with implanted metallic material. All vulnerable populations, including children, pregnant women, and cognitively impaired adult
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
Anthony Lucci, MD, 713-563-1871, ALucci@mdanderson.org
Anthony Lucci, MD
About this study
To find out whether the BIA test can help identify participants with IBC who are at risk for developing lymphedema.
Read the detailed description
Primary Objectives The primary objective is to reliably describe risk factors for development of BCRL in IBC using BIA.
- Being tested
- Neoadjuvant therapy
- Medical subject headings
- Lymphedema, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all patients will start/continue neoadjuvant systemic therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema Life Impact Scale (LLIS) questionnaire
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 posted2 Oct 2026
- Study start16 Sep 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Lucci, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855627
- Sponsor's protocol ID
- 2026-0423
- Other IDs
- NCI-2026-07135
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No