Screening For BCRL In Targeted Therapy For Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perometer, SOZO device.
- Who it may be relevant to
- Registry conditions: Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Lymphedema of Upper Limb. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer
Overview
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.
Interventions
- 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)
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 [Time frame: At least three months post surgery up to 5 years, assessed every 3 months]
Secondary outcome measures (2)
- To assess the time course to lymphedema onset [Time frame: 5 Years]
- To asses the correlation of different targeted therapies with lymphedema onset [Time frame: 5 Years]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT05142800 · 18-195