Screening for lymphedema in breast cancer patients
Prospective Screening for Breast Cancer-related Lymphedema: Analysis of Objective Measurements, Symptoms, Functionality, and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer.
Massachusetts General Hospital · NCT01521741
This study is trying to find out how to better spot lymphedema in breast cancer patients by checking their symptoms and quality of life before, during, and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT01521741 on ClinicalTrials.gov |
What this trial studies
This study aims to detect and assess symptoms, functional disability, and quality of life changes in breast cancer patients related to lymphedema. It involves collecting patient-reported outcomes, objective measurements, and clinical information to create a comprehensive database. The study utilizes a prospective design, where patients will undergo various assessments, including questionnaires and bioimpedance spectroscopy, before, during, and after their breast cancer treatment. The goal is to improve early detection of lymphedema and contribute valuable data to the existing literature.
Who should consider this trial
Good fit: Ideal candidates are patients with a confirmed diagnosis of breast cancer who can physically participate in the required measurements.
Not a fit: Patients with distant metastatic disease, previous breast cancer, or other medical conditions causing fluid retention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of lymphedema in breast cancer patients, enhancing their quality of life.
How similar studies have performed: Other studies have shown success in using similar screening approaches for lymphedema, indicating potential for this study's methodology.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Alphonse G Taghian, MD PhD — Massachusetts General Hospital
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphedema, Breast Cancer, Symptoms, Screening