Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

Screening for lymphedema in breast cancer patients

Official title: Prospective Screening for Breast Cancer-related Lymphedema: Analysis of Objective Measurements, Symptoms, Functionality, and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer.

Run by Massachusetts General Hospital · NCT01521741 · Data updated 2026-11-12

This study is trying to find out how to better spot lymphedema in breast cancer patients by checking their symptoms and quality of life before, during, and after treatment.

Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment10000 (estimated)
SponsorMassachusetts General Hospital
Academic / other
Locations1 site (Boston, Massachusetts)
StatusRecruiting
StartedAugust 2009
Main results expectedOctober 2027
Study endsDecember 2027
Registry record updatedNovember 10, 2026
Trial IDNCT01521741 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with a confirmed diagnosis of breast cancer who can physically participate in the required measurements.

Probably not a fit

Patients with distant metastatic disease, previous breast cancer, or other medical conditions causing fluid retention may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to detect and assess symptoms, functional disability, and quality of life changes in breast cancer patients related to lymphedema. It involves collecting patient-reported outcomes, objective measurements, and clinical information to create a comprehensive database. The study utilizes a prospective design, where patients will undergo various assessments, including questionnaires and bioimpedance spectroscopy, before, during, and after their breast cancer treatment. The goal is to improve early detection of lymphedema and contribute valuable data to the existing literature.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection and management of lymphedema in breast cancer patients, enhancing their quality of life.

How similar studies have gone: Other studies have shown success in using similar screening approaches for lymphedema, indicating potential for this study's methodology.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Confirmed diagnosis of breast cancer
* Ability to obtain physical positioning for perometry (e.g. abducting shoulder to 90 degrees) and BIS measurements (e.g. standing without aid)

Exclusion Criteria:

* Evidence of distant metastatic disease that may cause edema,
* Previous breast cancer
* History of lymphedema
* Pregnancy at the time of accrual and/or cardiac implants (contraindications for BIS)
* Medical conditions that cause fluid retention or swelling (e.g. axillary cancer recurrence, renal insufficiency, congestive heart failure).

Where it's running

  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting

Study contacts

  • Principal investigator: Alphonse G Taghian, MD PhD — Massachusetts General Hospital

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.