Screening For BCRL In Targeted Therapy For Breast Cancer

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05142800

Collaborator

Heinz Family Foundation (Other)

142

Enrollment

Location

93.6

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
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	Device: Perometer Device: SOZO device

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 142 participants

Study Design

Study Type:

Observational

Anticipated Enrollment :

142 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 13, 2018

Anticipated Primary Completion Date :

Sep 30, 2026

Anticipated Study Completion Date :

Sep 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
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	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)
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	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)

Arm

Intervention/Treatment

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

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)

Target Therapy-Early or Metastatic Breast Cancer

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)

Outcome Measures

Primary Outcome Measures

Proportion of participants with a greater than or equal to 10% arm volume change from the first pre-treatment (targeted therapy) measurement, detected by perometry, occurring at least three months after breast surgery [At least three months post surgery up to 5 years, assessed every 3 months]
Greater than or equal to 10% arm volume change from the first pre-treatment (targeted therapy) measurement, detected by perometry, occurring at least three months after breast surgery

Secondary Outcome Measures

Time course to lymphedema onset [5 Years]
The cumulative incidence curves of the study and control groups and comparing hazard rates after accounting for important covariates in a multivariate Cox proportional-hazards model
Correlation of different targeted therapies with lymphedema onset [5 Years]
Comparison of the incidence of lymphedema by type of targeted therapy drug (CDK4/6, PI3K, mTorr).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts 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.