Clinical trial NCT05142800: Screening For BCRL In Targeted Therapy For Breast Cancer
Official title: Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Heinz Family Foundation
First posted: 2021-12-03
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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).

Primary outcomes:
measure: 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
timeFrame: At least three months post surgery up to 5 years, assessed every 3 months
Secondary outcomes:
measure: To assess the time course to lymphedema onset
timeFrame: 5 Years
measure: To asses the correlation of different targeted therapies with lymphedema onset
timeFrame: 5 Years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Alphonse G. Taghian, MD
role: PRINCIPAL_INVESTIGATOR
References: