Screening For BCRL In Targeted Therapy For Breast Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05142800
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer
  • Breast Cancer Lymphedema
  • Breast Cancer Metastatic
  • Breast Cancer Stage
  • Edema
  • Edema Arm
  • Lymphedema
  • Lymphedema Arm
  • Lymphedema of Upper Arm
  • Lymphedema of Upper Limb
  • Lymphedema of the Hands

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Perometer — DEVICE
    The perometer uses light sensors to calculate the length and volume of your arms
  • SOZO device — DEVICE
    The machine measures the amount of fluid on the arm(s)

Study Details

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

Key Dates

First listed
Dec 3, 2021
Start date
Dec 13, 2018
Status verified
Jul 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
261 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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

Primary Outcome 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 [ Time Frame: At least three months post surgery up to 5 years, assessed every 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02115
Alphonse G. Taghian, MD
[email protected]
617-643-1306
Alphonse G. Taghian, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Massachusetts General Hospital· Boston, MA

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