Prospective Screening for Breast Cancer-related Lymphedema
ConditionLymphedema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMassachusetts General Hospital
About this trial
The primary objectives of this study are twofold: 1) to detect and determine the level of symptoms, functional disability, and changes in quality of life that breast cancer patients experience from changes in their arms during and after treatment for breast cancer by collecting patient reported outcome measures, objective measurements, and clinical information in a prospectively maintained database and 2) to improve breast cancer-related lymphedema outcomes by early detection using objective measurements and symptoms assessments and assess these outcomes by maintaining the data in a database in order to contribute to the literature. The secondary aim of this study is to assess extracellular fluid content in the upper extremity, breast, and/or trunk of patients treated for breast cancer before, during, and after treatment in order to better understand the role of bioimpedance spectroscopy in lymphedema screening.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of breast cancer
Ability to obtain physical positioning for perometry (e.g. abducting shoulder to 90 degrees) and BIS measurements (e.g. standing without aid)
Disqualifiers
Evidence of distant metastatic disease that may cause edema,
Previous breast cancer
History of lymphedema
Pregnancy at the time of accrual and/or cardiac implants (contraindications for BIS)
Trial population
Newly diagnosed breast cancer patients.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Breast Cancer-Related Lymphedema Screening
Other interventionAll patients enrolled in the trial will receive prospective BCRL screening from their pre-operative baseline throughout their breast cancer treatment process. All participants will be measured with perometry, bioimpedance spectroscopy, and patient-reported outcome measures.
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: Breast Cancer1 intervention
Trial outcomes
Primary outcomes
1
Upper extremity changes following treatment for breast cancer
During and following treatment for breast cancer patients' experience a variety of changes in their upper extremities. The subject responses to the patient-reported outcome measures (BCLE-SEI questionnaire) obtained throughout their breast cancer treatment process will be analyzed in conjunction with arm volume measurements taken with both perometry and bioimpedance spectroscopy. This will allow for the correlation between quantifiable limb volume changes and subject documented changes in arm use and functionality and quality of life.
Time frame
1.5 to 5 yearsSponsors and contacts
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Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov