Our team has ongoing clinical trials in order to further enrich Breast Cancer-Related Lymphedema research
Prospective Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer
Active and enrolling subjects
This clinical trial started in 2008 and is a lymphedema screening protocol for patients who have received breast cancer treatment at MGH. The trial consists of a patient-reported outcome measures regarding symptoms and distress associated with those symptoms, as well as objective measurements via the Perometer and SOZO technologies to measure arm volume or extracellular fluid content in the upper extremity, respectively. Our goal is to improve Breast Cancer-Related Lymphedema by using these symptom assessments and objective measurements to detect lymphedema early on and to understand the potential complementary role of bioimpedance spectroscopy for lymphedema screening.
As of July 2021, we have enrolled 3431 patients in this study.
Patient Experiences with the COVID-19 Vaccination after Lymph Node Removal for Breast Cancer
Active and enrolling subjects
This clinical trial started in 2021 in response to lymph node swelling being established as a known side-effect of the COVID-19 vaccine. The study consists of a survey asking patients about their experiences with the COVID-19 vaccine after lymph node removal. Questions include which limb they received the vaccine in, and if they had side effects and lymph node swelling after getting the vaccine. In the future, we plan to compare perometry measurements before and after receiving the vaccine in order to see how the vaccine may affect risk of Breast Cancer-Related Lymphedema.
As of July 2021, we have enrolled 540 patients in this study.
Evaluation of Risk of Lymphedema in Patients Treated by Surgery, +/- Chemotherapy, +/- Radiation for Breast Cancer
Active and enrolling subjects
This clinical trial started in 2005 and collects treatment and demographic information in REDCap to study the natural history and associated risk factors of Breast Cancer-Related Lymphedema.
As of October 2019, we have enrolled 5536 patients in this study.
Exploring the Efficacy of the LymphaTech Scanner for Breast Cancer-Related Lymphedema Screening
Opening soon!
- In this clinical trial, we plan to measure the absolute volume of the upper-extremity in women treated for breast cancer using both the Perometer and the LymphaTech 3D Scanner. Our goal is to assess agreement with arm volume measures via perometry and clinical feasibility of the Lymphatech scanner.
Our goal is to enroll 100 participants. Accrual has not yet started.
Screening for Edema and Breast-Cander-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer
Reopening soon!
- In this clinical trial, we screen for Breast Cancer-Related Lymphedema (BCRL) in patients undergoing targeted therapy (phosphoinoside-3-kinase/mechanistic target of rapamycin/cyclin-dependent kinases 4 and 6 (PI3K/mTOR/CDK4/6) inhibitors) for early or metastatic breast cancer. Screening measurements include arm volume via perometry, patient-reported outcome measures and clinical examinations. We will monitor the development of and responsiveness to treatment of BCRL in patients undergoing targeted therapy to understand the impact of therapeutic drugs targeting these cell signaling mechanisms on the incidence and severity of BCRL. We will also evaluate incidence and severity of BCRL in patients undergoing treatment with PI3K/mTOR/CDK4/6 inhibitors for early breast cancer as compared to those being treated for metastatic disease.
Estimated date for completion: December 2022
As of July 2018, we have enrolled 46 patients to participate in this study.
Evaluation of the Validity of Bioimpedance Spectroscopy as a Tool for Quantification of Lymphedema through Comparison with Perometry and Self-Report
Enrollment completed
- In this clinical trial, which started in 2011, we studied bioimpedance as a method to quantify lymphedema. To do so, we compared measurements from the bioimpedance spectroscopy machine to Perometer measurements and a self-reported assessment, and evaluated the relationship between impedance ratios, relative volume change, and self-reported symptoms. We compared the diagnostic criteria for lymphedema correlating with each method in order to define the natural time course of lymphedema and determine a threshold for intervention using bioimpedance spectroscopy.
Study enrollment is completed with a total enrollment of 270 patients.
Evaluation of Methods of Upper Extremity Measurement for Breast Cancer-Related Lymphedema: a Comparison and Cost Analysis of Perometry, Circumferential Tape Measurement, and Bioimpedance Spectroscopy
Enrollment completed
- In this clinical trial, which started in 2015, we compared the upper extremity measurements for Breast Cancer-Related Lymphedema via perometry, circumferential tape measurement, and bioimpedence spectroscopy. We assessed the differences of limb volume calculation via these tools as a way to discriminate between patients who have 0-5%, 5-10%, and >10% swelling. We also analyzed the agreement between limb volume calculation via girth measures done through NLN guidelines (gather the circumference at the mid-hand, wrist, 10 cm distal to the lateral epicondyle and 10 cm proximal to the lateral epicondyle on both arms) and girth measures done every 4 cm.
Study enrollment is completed with a total enrollment of 60 patients.