NCT01521741 Prospective Screening for Breast Cancer-related Lymphedema
| NCT ID | NCT01521741 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Lymphedema |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2009-08 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2009-08 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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) Exclusion Criteria: * 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) * Medical conditions that cause fluid retention or swelling (e.g. axillary cancer recurrence, renal insufficiency, congestive heart failure).
Contact & Investigator
Alphonse G Taghian, MD PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT01521741 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01521741 currently recruiting?
Yes, NCT01521741 is actively recruiting participants. Visit ClinicalTrials.gov or contact Massachusetts General Hospital to inquire about joining.
Where is the NCT01521741 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT01521741 clinical trial?
NCT01521741 is sponsored by Massachusetts General Hospital. The principal investigator is Alphonse G Taghian, MD PhD at Massachusetts General Hospital. The trial plans to enroll 10,000 participants.