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Prospective Screening for Breast Cancer-related Lymphedema

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ClinicalTrials.gov Identifier: NCT01521741
Recruitment Status : Recruiting
First Posted : January 31, 2012
Last Update Posted : August 26, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alphonse Taghian, MD, PhD, Massachusetts General Hospital

Tracking Information
First Submitted Date September 6, 2011
First Posted Date January 31, 2012
Last Update Posted Date August 26, 2020
Study Start Date August 2009
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 24, 2020)
Upper extremity changes following treatment for breast cancer [ Time Frame: 1.5 to 5 years ]
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.
Original Primary Outcome Measures
 (submitted: January 26, 2012)
Upper extremity changes following treatment for breast cancer [ Time Frame: 1.5 to 5 years ]
During and following treatment for breast cancer patients' experience a variety of changes in their upper extremities. The subject responses to the LEFT-BC questionnaire obtained at the mandated study points will be analyzed in conjunction with a arm volume measurement. This will allow for the correlation between quantifiable limb volume changes and subject documented changes in arm use and functionality and quality of life.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Screening for Breast Cancer-related Lymphedema
Official Title 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.
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.
Detailed Description

The goal of the study is to create a large, prospectively maintained database with data from multiple objective measurement methods (i.e. perometry and BIS) that has detailed information on patient's symptoms and quality of life measures that can be used to answer research questions.

The study design is prospective in nature, and a questionnaire will be utilized in conjunction with objective measurements before, throughout, and after a patient's treatment for breast cancer. This protocol is designed to mimic the current standard of care screening program with the addition of the quality of life questionnaire and BIS measurements.

Data collection will include medical chart review, perometric arm volume measurements, BIS measurements, and a subjective questionnaire. At their preoperative multidisciplinary breast cancer clinic appointment, patients will undergo baseline arm volume measurements per standard of care. At this time, eligible patients will be offered this study. Those who consent will be given a baseline questionnaire to fill out and have baseline BIS measurements taken. Throughout their treatment and follow-up, patients will periodically have BCRL screening every 2-12 months depending on their risk (i.e. patients who are high risk for BCRL because of extensive lymph node surgery will be measured more often than patients who did not have lymph nodes removed). These screening visits will coincide with naturally occurring oncology follow-up visits; although, patients are also screened when patient or provider requests and questionnaires/BIS measurements will be offered at these time points as well.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Newly diagnosed breast cancer patients.
Condition Lymphedema
Intervention Other: Breast Cancer-Related Lymphedema Screening
All 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.
Study Groups/Cohorts Breast Cancer
Intervention: Other: Breast Cancer-Related Lymphedema Screening
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 24, 2020)
10000
Original Estimated Enrollment
 (submitted: January 26, 2012)
2500
Estimated Study Completion Date December 2026
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01521741
Other Study ID Numbers 08-540
R01CA139118 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Alphonse Taghian, MD, PhD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Alphonse G Taghian, MD PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2020