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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05142800
Other study ID # 18-195
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 13, 2018
Est. completion date September 30, 2026

Study information

Verified date October 2023
Source Massachusetts General Hospital
Contact Alphonse G. Taghian, MD
Phone 617-643-1306
Email ataghian@partners.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 142
Est. completion date September 30, 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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).

Study Design


Intervention

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

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Heinz Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Time course to lymphedema onset 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 5 Years
Secondary Correlation of different targeted therapies with lymphedema onset Comparison of the incidence of lymphedema by type of targeted therapy drug (CDK4/6, PI3K, mTorr). 5 Years
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