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Screening for Breast Cancer-Related Lymphedema

This study is looking at how to best detect and understand breast cancer-related lymphedema (swelling in the arm or hand) in women who have been diagnosed with breast cancer. Researchers will use "Breast Cancer-Related Lymphedema Screening" which involves measuring arm size (perometry), electrical resistance in the arm (bioimpedance spectroscopy), and asking about your symptoms and quality of life. The goal is to improve early detection of lymphedema and understand its impact over time. You can join if you are a woman aged 18 or older with a confirmed breast cancer diagnosis and can perform the necessary physical movements for measurements. The study aims to follow participants for 1.5 to 5 years to see changes in their upper extremities.

Study design
This is an observational study, meaning researchers will collect information without giving new treatments. It plans to include 10,000 participants.
What's involved
You will have baseline measurements and questionnaires before treatment. Throughout your treatment and follow-up, you will have lymphedema screenings every 2-12 months, depending on your risk.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 1.5 to 5 years after breast cancer treatment to observe changes in their upper extremities.

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NCT01521741

Prospective Screening for Breast Cancer-related Lymphedema

Recruiting
Not specifiedAges 18+Observational
Massachusetts General Hospital
~10,000 participants
Updated 2025-12-24 on ClinicalTrials.gov
What's tested:Breast Cancer-Related Lymphedema Screening

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Upper extremity changes following treatment for breast cancer
Measured over 1.5 to 5 years

Conditions

Lymphedema

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Alphonse G Taghian, MD PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Alphonse G Taghian, MD PhD
[email protected]
617-726-6050
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Upper extremity changes following treatment for breast cancer1.5 to 5 years

    During and following treatment for breast cancer patients' experience a variety of changes in their upper extremities. The subject responses to the patient-reported outcome measures (BCLE-SEI questionnaire) obtained throughout their breast cancer treatment process will be analyzed in conjunction with arm volume measurements taken with both perometry and bioimpedance spectroscopy. This will allow for the correlation between quantifiable limb volume changes and subject documented changes in arm use and functionality and quality of life.