Screening For BCRL In Targeted Therapy For Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-13

Study Completion Date

2026-09-30

Brief Summary

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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

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Detailed Description

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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

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Target Therapy Drug-Stand Care

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

Perometer

Intervention Type DEVICE

The perometer uses light sensors to calculate the length and volume of your arms

SOZO device

Intervention Type DEVICE

The machine measures the amount of fluid on the arm(s)

Target Therapy-Early or Metastatic Breast Cancer

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

Perometer

Intervention Type DEVICE

The perometer uses light sensors to calculate the length and volume of your arms

SOZO device

Intervention Type DEVICE

The machine measures the amount of fluid on the arm(s)

Interventions

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Perometer

The perometer uses light sensors to calculate the length and volume of your arms

Intervention Type DEVICE

SOZO device

The machine measures the amount of fluid on the arm(s)

Intervention Type DEVICE

Eligibility Criteria

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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.