Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT01521741

Conditions

Lymphedema

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Breast Cancer-Related Lymphedema Screening

Study Details

Brief summary:

The primary objectives of this study are twofold: 1) to detect and determine the level of symptoms, functional disability, and changes in quality of life that breast cancer patients experience from changes in their arms during and after treatment for breast cancer by collecting patient reported outcome measures, objective measurements, and clinical information in a prospectively maintained database and 2) to improve breast cancer-related lymphedema outcomes by early detection using objective measurements and symptoms assessments and assess these outcomes by maintaining the data in a database in order to contribute to the literature. The secondary aim of this study is to assess extracellular fluid content in the upper extremity, breast, and/or trunk of patients treated for breast cancer before, during, and after treatment in order to better understand the role of bioimpedance spectroscopy in lymphedema screening.

Conditions

Lymphedema

Study ID

NCT01521741

Start date

Aug, 2009

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Breast Cancer

Interventions

Breast Cancer-Related Lymphedema Screening

All patients enrolled in the trial will receive prospective BCRL screening from their pre-operative baseline throughout their breast cancer treatment process. All participants will be measured with perometry, bioimpedance spectroscopy, and patient-reported outcome measures.

Primary outcome measure

  • Upper extremity changes following treatment for breast cancer [ Time Frame: 1.5 to 5 years ]

Central Contacts and Locations

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02134

Contacts

Alphonse G Taghian, MD PhD

617-726-6050ataghian@partners.org

Principal Investigator:

Alphonse G Taghian, MD PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • Breast Cancer
  • Lymphedema
  • Symptoms
  • Screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-12-24.