Prospective Screening for Breast Cancer-related Lymphedema

NCT01521741 | Recruiting

• 2 other identifiers: 08-540R01CA139118
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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

Keywords

Breast Cancer; Lymphedema; Symptoms; Screening

Outcome Measures

Primary Outcomes (1)

• Upper extremity changes following treatment for breast cancer

  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.

  1.5 to 5 years

Study Arms (1)

Breast Cancer

Other: Breast Cancer-Related Lymphedema Screening

Interventions

Breast Cancer-Related Lymphedema Screening OTHER

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.

Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed breast cancer patients.

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02134, United States

RECRUITING

Related Publications (3)

• Ancukiewicz M, Miller CL, Skolny MN, O'Toole J, Warren LE, Jammallo LS, Specht MC, Taghian AG. Comparison of relative versus absolute arm size change as criteria for quantifying breast cancer-related lymphedema: the flaws in current studies and need for universal methodology. Breast Cancer Res Treat. 2012 Aug;135(1):145-52. doi: 10.1007/s10549-012-2111-8. Epub 2012 Jun 19.

  PMID: 22710706 BACKGROUND

• Ancukiewicz M, Russell TA, Otoole J, Specht M, Singer M, Kelada A, Murphy CD, Pogachar J, Gioioso V, Patel M, Skolny M, Smith BL, Taghian AG. Standardized method for quantification of developing lymphedema in patients treated for breast cancer. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1436-43. doi: 10.1016/j.ijrobp.2010.01.001. Epub 2010 Jun 3.

  PMID: 20605339 BACKGROUND

• Brunelle CL, Roberts SA, Horick NK, Gillespie TC, Jacobs JM, Daniell KM, Naoum GE, Taghian AG. Integrating Symptoms Into the Diagnostic Criteria for Breast Cancer-Related Lymphedema: Applying Results From a Prospective Surveillance Program. Phys Ther. 2020 Dec 7;100(12):2186-2197. doi: 10.1093/ptj/pzaa162.

  PMID: 32931555 DERIVED

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alphonse G Taghian, MD PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Breast Service

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: January 31, 2012
• Study Start: August 1, 2009
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)