Trial Outcomes & Findings for Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status (NCT NCT00383500)
NCT ID: NCT00383500
Last Updated: 2017-03-30
Results Overview
Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
36 months
Results posted on
2017-03-30
Participant Flow
Enrollment commenced in May 2005 and concluded 13 March 2012. Subjects were recruited from the medical clinics and Stanford University Hospital and Clinics.
Participant milestones
| Measure |
Flexitouch Device
Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
|
Manual Lymphatic Drainage (MLD)
Lymphedema management via self-administered manual lymphatic massage therapy
|
No Intervention Control
No intervention observational control
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
24
|
24
|
|
Overall Study
COMPLETED
|
19
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
2
|
Reasons for withdrawal
| Measure |
Flexitouch Device
Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
|
Manual Lymphatic Drainage (MLD)
Lymphedema management via self-administered manual lymphatic massage therapy
|
No Intervention Control
No intervention observational control
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
Baseline Characteristics
Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status
Baseline characteristics by cohort
| Measure |
Group I
n=27 Participants
This group of patients will receive the device.
|
Group II
n=24 Participants
This group of patients will receive prophylactic MLD
|
Group III
n=24 Participants
This is the control group; they will receive no treatment
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: All enrolled patients in the trial who did not withdraw or were lost to follow-up
Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups
Outcome measures
| Measure |
Flexitouch Device
n=19 Participants
Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
|
Manual Lymphatic Drainage (MLD)
n=21 Participants
Lymphedema management via self-administered manual lymphatic drainage therapy
|
No Intervention Control
n=22 Participants
No intervention observational control
|
|---|---|---|---|
|
Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy
|
19 participants
|
21 participants
|
22 participants
|
PRIMARY outcome
Timeframe: 3 years of semi-annual follow-upIncidence of newly-developing lymphedema for each study cohort, as detected by serial multiple frequency bioimpedance spectroscopy scans for increased interstitial fluid within regional tissues.
Outcome measures
| Measure |
Flexitouch Device
n=19 Participants
Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
|
Manual Lymphatic Drainage (MLD)
n=21 Participants
Lymphedema management via self-administered manual lymphatic drainage therapy
|
No Intervention Control
n=22 Participants
No intervention observational control
|
|---|---|---|---|
|
Incidence of Lymphedema (Newly-developing)
|
1 participants
|
5 participants
|
5 participants
|
Adverse Events
Flexitouch Device
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Manual Lymphatic Drainage (MLD)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Observational Control (no Intervention)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flexitouch Device
n=19 participants at risk
Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
|
Manual Lymphatic Drainage (MLD)
n=21 participants at risk
Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment.
|
Observational Control (no Intervention)
n=22 participants at risk
Control group, no intervention. No Flexitouch or manual massage therapy
|
|---|---|---|---|
|
Vascular disorders
Lymphedema
|
5.3%
1/19 • Number of events 1 • 1 year
|
23.8%
5/21 • Number of events 5 • 1 year
|
22.7%
5/22 • Number of events 5 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place