Screening for BCRL in Targeted Therapy for Breast Cancer
Purpose
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
Conditions
- 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
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- Female
- Accepts 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).
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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 |
|
| 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 |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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.