Recruiting

BCRL Tracking

Sponsor:

Massachusetts General Hospital

Code:

NCT05142800

Conditions

Lymphedema

Lymphedema Arm

Lymphedema of Upper Arm

Lymphedema of Upper Limb

Lymphedema of the Hands

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Perometer

SOZO device

Study Details

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

Conditions

Lymphedema

Lymphedema Arm

Lymphedema of Upper Arm

Lymphedema of Upper Limb

Lymphedema of the Hands

Study ID

NCT05142800

Start date

Dec 13, 2018

Status verified date

Jul, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

261 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Perometer

The perometer uses light sensors to calculate the length and volume of your arms

SOZO device

The machine measures the amount of fluid on the arm(s)

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 and Locations

Central contacts

Alphonse G. Taghian, MD

617-643-1306ataghian@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Alphonse G. Taghian, MD

617-643-1306ataghian@partners.org

Principal Investigator:

Alphonse G. Taghian, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-13.