NCT05142800

Screening For BCRL In Targeted Therapy For Breast Cancer

Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 166 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer. A Perometer and Sozo devise will be used to measure volume changes

Detailed description

This study will compare patients' relative arm volume changes and symptoms data from before drug therapy throughout drug treatment and for up to six months after treatment has finished. A Perometer and Sozo device will be used to measure volume changes All participants will be accrued at Massachusetts General Hospital for a target accrual of 166 participants.

Conditions

• Lymphedema
• Lymphedema Arm
• Lymphedema of Upper Arm
• Lymphedema of Upper Limb
• Lymphedema of the Hands
• Edema
• Edema Arm
• Breast Cancer Lymphedema
• Breast Cancer Metastatic
• Breast Cancer Stage
• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Perometer	The perometer uses light sensors to calculate the length and volume of your arms
DEVICE	SOZO device	The machine measures the amount of fluid on the arm(s)

Timeline

• Start date: 2018-12-13
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2021-12-03
• Last updated: 2025-05-22

Locations

1 site across 1 country: United States