LymphedemaNCT05142800
Screening For BCRL In Targeted Therapy For Breast Cancer
An observational study of Lymphedema and Lymphedema Arm, run by Massachusetts General Hospital at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm
- What is being tested?
- Perometer and SOZO device
- Type of treatment
- Medical device
- How many people
- 261 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2018to 30 Sep 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02115
Alphonse G. Taghian, MD, 617-643-1306, ataghian@partners.org
Alphonse G. Taghian, MD
About this study
Official title: Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer
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
Read the 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.
- Conditions
- Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Lymphedema of Upper Limb, Lymphedema of the Hands, Edema
- Being tested
- Perometer, SOZO device
- 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
- Medical subject headings
- Lymphedema, Edema, Breast Cancer Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerometerDevice
The perometer uses light sensors to calculate the length and volume of your arms
SOZO deviceDevice
The machine measures the amount of fluid on the arm(s)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Perometer; Device: SOZO device | |
| 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 Receives: Device: Perometer; Device: SOZO device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: At least three months post surgery up to 5 years, assessed every 3 months
Secondary outcomes (2)
To assess the time course to lymphedema onset
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.
Measured: 5 Years
To asses the correlation of different targeted therapies with lymphedema onset
We will compare the incidence of lymphedema by type of targeted therapy drug (CDK4/6, PI3K, mTOR, AKT).
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start13 Dec 2018
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 261 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Heinz Family Foundation
- Responsible party
- Principal investigator, Alphonse Taghian, Massachusetts General Hospital
- Investigators
- Alphonse G. Taghian, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142800
- Sponsor's protocol ID
- 18-195
- Status last verified
- Jul 2026
- First submitted
- 15 Nov 2021
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.