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Arm Circumference Measurement With or Without Bioimpedance Spectroscopy in Finding Lymphedema Early in Patients With Stage I-III Breast Cancer

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ClinicalTrials.gov Identifier: NCT03648983
Recruitment Status : Terminated (Pi departure; service discontinued study)
First Posted : August 28, 2018
Results First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Albert Einstein College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Lymphedema
Breast Cancer
Interventions Procedure: arm circumference measurement
Device: Bioimpedance spectroscopy
Enrollment 95
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Population
Hide Arm/Group Description Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.
Period Title: Overall Study
Started 95
Completed 0
Not Completed 95
Reason Not Completed
Study was terminated due to PI departure             95
Arm/Group Title Study Population
Hide Arm/Group Description Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.
Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
Race (NIH/OMB)  
Number Analyzed 0 participants
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
1.Primary Outcome
Title Rates of Enhanced Lymphedema Detection
Hide Description

Rates of enhanced lymphedema detection will be compared between the enhanced versus standard detection groups with the Fisher’s exact test. Adjustment for potential imbalances in patient characteristics will be accomplished by fitting logistic and Cox proportional hazards regression models.

*** Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.***

Time Frame During treatment (Up to 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
*** Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.***
Arm/Group Title Study Population
Hide Arm/Group Description:
Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Severity of Enhanced Lymphedema
Hide Description Severity of LE in terms of changes in arm circumference at the site of greatest difference and L-Dex change, will be compared between the enhanced versus standard detection groups with the Fisher’s exact test. Adjustment for potential imbalances in patient characteristics will be accomplished by fitting logistic and Cox proportional hazards regression models.
Time Frame During treatment (Up to 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
*** Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.***
Arm/Group Title Study Population
Hide Arm/Group Description:
*** Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.***
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Subjects With Complete Resolution of Signs of Enhanced Lymphedema
Hide Description The Fisher’s exact test will be used to compare between the enhanced vs. standard detection groups the percentage of subjects with complete resolution of signs and symptoms of LE following treatment with a compression garment. Logistic regression models will also be fit to the data to adjust for potential confounders.
Time Frame During treatment (up to 34 months) plus 1 year post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
*** Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.***
Arm/Group Title Study Population
Hide Arm/Group Description:
Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame *** Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.***
Adverse Event Reporting Description *** Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.***
 
Arm/Group Title Study Population
Hide Arm/Group Description Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.
All-Cause Mortality
Study Population
Affected / at Risk (%)
Total   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Study Population
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Population
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Lisa Wiechmann
Organization: Montefiore Medical Center
Responsible Party: Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03648983     History of Changes
Other Study ID Numbers: 11-06-235
NCI-2014-01480 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
11-06-235E ( Other Identifier: Albert Einstein College of Medicine )
11-047 ( Other Identifier: Albert Einstein College of Medicine )
LDEX ( Other Identifier: Albert Einstein College of Medicine )
P30CA013330 ( U.S. NIH Grant/Contract )
First Submitted: October 8, 2015
First Posted: August 28, 2018
Results First Submitted: August 31, 2018
Results First Posted: October 1, 2018
Last Update Posted: October 1, 2018