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Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status

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ClinicalTrials.gov Identifier: NCT00383500
Recruitment Status : Completed
First Posted : October 3, 2006
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Stanley Rockson, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Lymphedema
Breast Cancer
Interventions Device: Flexitouch
Device: Class 1 compression garment
Enrollment 75
Recruitment Details Enrollment commenced in May 2005 and concluded 13 March 2012. Subjects were recruited from the medical clinics and Stanford University Hospital and Clinics.
Pre-assignment Details  
Arm/Group Title Flexitouch Device Manual Lymphatic Drainage (MLD) No Intervention Control
Hide Arm/Group Description Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump) Lymphedema management via self-administered manual lymphatic massage therapy No intervention observational control
Period Title: Overall Study
Started 27 24 24
Completed 19 21 22
Not Completed 8 3 2
Reason Not Completed
Withdrawal by Subject             8             3             0
Lost to Follow-up             0             0             2
Arm/Group Title Group I Group II Group III Total
Hide Arm/Group Description This group of patients will receive the device. This group of patients will receive prophylactic MLD This is the control group; they will receive no treatment Total of all reporting groups
Overall Number of Baseline Participants 27 24 24 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 24 participants 24 participants 75 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
  88.9%
22
  91.7%
19
  79.2%
65
  86.7%
>=65 years
3
  11.1%
2
   8.3%
5
  20.8%
10
  13.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 24 participants 24 participants 75 participants
Female
27
 100.0%
24
 100.0%
24
 100.0%
75
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 24 participants 24 participants 75 participants
Hispanic or Latino
1
   3.7%
2
   8.3%
0
   0.0%
3
   4.0%
Not Hispanic or Latino
26
  96.3%
22
  91.7%
24
 100.0%
72
  96.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 24 participants 24 participants 75 participants
American Indian or Alaska Native
0
   0.0%
1
   4.2%
0
   0.0%
1
   1.3%
Asian
4
  14.8%
2
   8.3%
3
  12.5%
9
  12.0%
Native Hawaiian or Other Pacific Islander
2
   7.4%
0
   0.0%
0
   0.0%
2
   2.7%
Black or African American
2
   7.4%
0
   0.0%
0
   0.0%
2
   2.7%
White
17
  63.0%
20
  83.3%
20
  83.3%
57
  76.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   7.4%
1
   4.2%
1
   4.2%
4
   5.3%
1.Primary Outcome
Title Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy
Hide Description Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients in the trial who did not withdraw or were lost to follow-up
Arm/Group Title Flexitouch Device Manual Lymphatic Drainage (MLD) No Intervention Control
Hide Arm/Group Description:
Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
Lymphedema management via self-administered manual lymphatic drainage therapy
No intervention observational control
Overall Number of Participants Analyzed 19 21 22
Measure Type: Number
Unit of Measure: participants
19 21 22
2.Primary Outcome
Title Incidence of Lymphedema (Newly-developing)
Hide Description Incidence of newly-developing lymphedema for each study cohort, as detected by serial multiple frequency bioimpedance spectroscopy scans for increased interstitial fluid within regional tissues.
Time Frame 3 years of semi-annual follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flexitouch Device Manual Lymphatic Drainage (MLD) No Intervention Control
Hide Arm/Group Description:
Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
Lymphedema management via self-administered manual lymphatic massage therapy
No intervention observational control
Overall Number of Participants Analyzed 19 21 22
Measure Type: Number
Unit of Measure: participants
1 5 5
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flexitouch Device Manual Lymphatic Drainage (MLD) Observational Control (no Intervention)
Hide Arm/Group Description Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump) Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment. Control group, no intervention. No Flexitouch or manual massage therapy
All-Cause Mortality
Flexitouch Device Manual Lymphatic Drainage (MLD) Observational Control (no Intervention)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Flexitouch Device Manual Lymphatic Drainage (MLD) Observational Control (no Intervention)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/21 (0.00%)      0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Flexitouch Device Manual Lymphatic Drainage (MLD) Observational Control (no Intervention)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/19 (5.26%)      5/21 (23.81%)      5/22 (22.73%)    
Vascular disorders       
Lymphedema * 1  1/19 (5.26%)  1 5/21 (23.81%)  5 5/22 (22.73%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE v4
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Stanley G. Rockson
Organization: Stanford University
Phone: 650-725-7571
Responsible Party: Stanley Rockson, Stanford University
ClinicalTrials.gov Identifier: NCT00383500     History of Changes
Other Study ID Numbers: IRB-01671
95970 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BRSNSTU0007 ( Other Identifier: OnCore Number )
First Submitted: September 29, 2006
First Posted: October 3, 2006
Results First Submitted: June 6, 2012
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017