Screening For BCRL In Targeted Therapy For Breast Cancer

Mass General Brigham

Status: Active, not recruiting

Conditions: Breast Cancer Lymphedema; Edema; Lymphedema Arm; Lymphedema of the Hands; Breast Cancer; Lymphedema of Upper Arm; Lymphedema of Upper Limb; Breast Cancer Metastatic; Lymphedema; Breast Cancer Stage; Edema Arm

Treatments: Device: Perometer; Device: SOZO device

Study type: Observational

Funder types: Other

Identifiers

NCT05142800

18-195

Details and patient eligibility

About

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

Full 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.

Enrollment: 166 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF/HCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible.
• Subjects that will be eligible for the study include:
• Females between 18 and 80 years of age
• With a history of breast cancer
• 4 weeks or more post-surgery
• With or without edema
• Undergoing treatment with targeted therapy for early or metastatic disease.

Exclusion criteria

• Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer).

Trial design

166 participants in 2 patient groups

Target Therapy Drug-Stand Care

Description:

Screening procedures confirm participation in the research study. * Participants limb volume is measured prior to treatment start date. * Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card. * Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication

Treatment:

Device: SOZO device

Device: Perometer

Target Therapy-Early or Metastatic Breast Cancer

Description:

Screening procedures confirm participation in the research study. * Participants limb volume is measured prior to treatment start date. * Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card. * Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication

Treatment:

Device: SOZO device

Device: Perometer