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Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer

This study has been terminated.
(Loss of principal investigator)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00932035
First received: June 29, 2009
Last updated: May 5, 2017
Last verified: May 2017
Results First Received: December 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Supportive Care
Condition: Breast Cancer
Interventions: Procedure: axillary lymph node dissection
Drug: isosulfan blue based lymphatic mapping
Procedure: quality-of-life assessment
Other: Questionnaire administration

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)

Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.

axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection

isosulfan blue based lymphatic mapping

quality-of-life assessment: Ancillary studies

Arm II (Control)

Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.

isosulfan blue based lymphatic mapping

axillary lymph node dissection: Undergo standard axillary lymph node dissection

quality-of-life assessment: Ancillary studies

Questionnaire administration: Ancillary studies


Participant Flow:   Overall Study
    Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)   Arm II (Control)
STARTED   18   21 
COMPLETED   18   21 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)

Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.

axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection

isosulfan blue based lymphatic mapping

quality-of-life assessment: Ancillary studies

Arm II (Control)

Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.

isosulfan blue based lymphatic mapping

axillary lymph node dissection: Undergo standard axillary lymph node dissection

quality-of-life assessment: Ancillary studies

Questionnaire administration: Ancillary studies

Total Total of all reporting groups

Baseline Measures
   Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)   Arm II (Control)   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   21   39 
Age 
[Units: Years]
Median (Full Range)
 52 
 (28 to 81) 
 47 
 (32 to 73) 
 50 
 (28 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18 100.0%      21 100.0%      39 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   18   21   39 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein   [ Time Frame: Up to 4 years ]

2.  Primary:   Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes   [ Time Frame: Up to 4 years ]

3.  Primary:   Percentage of Patients With Lymphedema   [ Time Frame: Up to 4 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated early due to loss of principal investigator. As a result accrual of subjects and data collection are incomplete.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Carolyn Behrendt, Ph.D.
Organization: City of Hope
phone: (626)359-8111 ext 61148
e-mail: Cbehrendt@coh.org



Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00932035     History of Changes
Other Study ID Numbers: 11130
Study First Received: June 29, 2009
Results First Received: December 9, 2016
Last Updated: May 5, 2017