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
Conditions
Keywords
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
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.
Interventions
DEVICEPerometer
The perometer uses light sensors to calculate the length and volume of your arms
DEVICESOZO device
The machine measures the amount of fluid on the arm(s)
Sponsors
Heinz Family Foundation
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| To assess the time course to lymphedema onset | 5 Years | We will also attempt to look at any time course differences of lymphedema onset by plotting 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. |
| To asses the correlation of different targeted therapies with lymphedema onset | 5 Years | We will compare the incidence of lymphedema by type of targeted therapy drug (CDK4/6, PI3K, mTOR, AKT). |
Countries
United States
Outcome results
None listed