Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lymphedema
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 166
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
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
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.
Investigators
Alphonse Taghian
Principal Investigator
Massachusetts General Hospital
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).
Outcomes
Primary Outcomes
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
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 Outcomes
- To assess the time course to lymphedema onset(5 Years)
- To asses the correlation of different targeted therapies with lymphedema onset(5 Years)