Trial Outcomes & Findings for A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients (NCT NCT04073823)
NCT ID: NCT04073823
Last Updated: 2023-01-18
Results Overview
Comparison of the change in the rate of lymphatic propulsion events from the pre-treatment values to the post-treatment values for both the affected and contralateral limbs using the investigational technique of near infrared-fluorescent (NIRF) imaging.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
Baseline and following a single treatment, an average of one hour
Results posted on
2023-01-18
Participant Flow
Participant milestones
| Measure |
Flexitouch Plus
Flexitouch Plus: Flexitouch Plus full arm and core treatment
|
Flexitouch Plus With SW
Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients
Baseline characteristics by cohort
| Measure |
Flexitouch Plus
n=1 Participants
Flexitouch Plus: Flexitouch Plus full arm and core treatment
|
Flexitouch Plus With SW
n=1 Participants
Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
81 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and following a single treatment, an average of one hourComparison of the change in the rate of lymphatic propulsion events from the pre-treatment values to the post-treatment values for both the affected and contralateral limbs using the investigational technique of near infrared-fluorescent (NIRF) imaging.
Outcome measures
| Measure |
Flexitouch Plus
n=1 Participants
Flexitouch Plus: Flexitouch Plus full arm and core treatment
|
Flexitouch Plus With SW
n=1 Participants
Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
|
|---|---|---|
|
Lymphatic Activation
Affected Limb
|
0.0 Percent Rate Change
|
-50 Percent Rate Change
|
|
Lymphatic Activation
Contralateral Limb
|
-3.0 Percent Rate Change
|
241.2 Percent Rate Change
|
PRIMARY outcome
Timeframe: Baseline and following a single treatment, an average of one hourComparison of the percent change in local tissue water from the pre-treatment values to the post-treatment values on the affected limb using MoistureMeterD.
Outcome measures
| Measure |
Flexitouch Plus
n=1 Participants
Flexitouch Plus: Flexitouch Plus full arm and core treatment
|
Flexitouch Plus With SW
n=1 Participants
Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
|
|---|---|---|
|
Changes in Swelling - MoistureMeterD
|
-4.0 Percent Change
Interval -7.4 to 0.0
|
-6.4 Percent Change
Interval -11.4 to 3.8
|
PRIMARY outcome
Timeframe: Baseline and following a single treatment, an average of one hourSwelling in the affected and contralateral limb as assessed using local tissue water content
Outcome measures
| Measure |
Flexitouch Plus
n=1 Participants
Flexitouch Plus: Flexitouch Plus full arm and core treatment
|
Flexitouch Plus With SW
n=1 Participants
Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
|
|---|---|---|
|
Changes in Swelling - Perometry
Contralateral Limb
|
0.5 Percent Change
|
0.7 Percent Change
|
|
Changes in Swelling - Perometry
Affected Limb
|
1.6 Percent Change
|
-1.6 Percent Change
|
PRIMARY outcome
Timeframe: Baseline and following a single treatment, an average of one hourSkin changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Outcome measures
| Measure |
Flexitouch Plus
n=1 Participants
Flexitouch Plus: Flexitouch Plus full arm and core treatment
|
Flexitouch Plus With SW
n=1 Participants
Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
|
|---|---|---|
|
Percent Change in Skin Thickness From Baseline to After Treatment.
Affected Limb Percent Change
|
116.1 Percent Change
Interval -46.5 to 310.3
|
5.6 Percent Change
Interval -17.0 to 76.1
|
|
Percent Change in Skin Thickness From Baseline to After Treatment.
Contralateral Limb Percent Change
|
15.2 Percent Change
Interval -56.4 to 106.9
|
184.2 Percent Change
Interval -4.3 to 670.8
|
PRIMARY outcome
Timeframe: 24-Hour Follow-UpAdverse events reported between treatment and the 24-hour follow-up
Outcome measures
| Measure |
Flexitouch Plus
n=1 Participants
Flexitouch Plus: Flexitouch Plus full arm and core treatment
|
Flexitouch Plus With SW
n=1 Participants
Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
|
|---|---|---|
|
Incidence of Adverse Events
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and following a single treatment, an average of one hourComparison of the number of subjects with an increase in vessels for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging.
Outcome measures
| Measure |
Flexitouch Plus
n=1 Participants
Flexitouch Plus: Flexitouch Plus full arm and core treatment
|
Flexitouch Plus With SW
n=1 Participants
Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
|
|---|---|---|
|
Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging
Contralateral Limb
|
1 Participants
|
1 Participants
|
|
Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging
Affected Limb
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and following a single treatment, an average of one hourComparison of the change in dermal backflow from the pre-treatment values to the post-treatment values as the sum of the volume of area for all locations for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging
Outcome measures
| Measure |
Flexitouch Plus
n=1 Participants
Flexitouch Plus: Flexitouch Plus full arm and core treatment
|
Flexitouch Plus With SW
n=1 Participants
Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
|
|---|---|---|
|
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
Affected Limb (Medial Upper)
|
47.8 Percent Change
|
0.0 Percent Change
|
|
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
Contralateral Limb (Medial Upper)
|
0.0 Percent Change
|
0.0 Percent Change
|
|
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
Affected Limb (Lateral Lower)
|
65.4 Percent Change
|
20.6 Percent Change
|
|
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
Contralateral Limb (Lateral Lower)
|
0.0 Percent Change
|
0.0 Percent Change
|
|
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
Affected Limb (Medial Lower)
|
19.0 Percent Change
|
-19.8 Percent Change
|
|
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
Contralateral Limb (Medial Lower)
|
0.0 Percent Change
|
0.0 Percent Change
|
PRIMARY outcome
Timeframe: Baseline and following a single treatment, an average of one hourCompare the percent of participants by arm demonstrating a decrease in limb volume for the affected and contralateral limbs via Perometry (LymphaTech 3D Scanner)
Outcome measures
| Measure |
Flexitouch Plus
n=1 Participants
Flexitouch Plus: Flexitouch Plus full arm and core treatment
|
Flexitouch Plus With SW
n=1 Participants
Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
|
|---|---|---|
|
Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner)
Affected Limb
|
0 Percentage of Participants
|
100 Percentage of Participants
|
|
Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner)
Contralateral Limb
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline and following a single treatment, an average of one hourComparison of the percent of participants by arm demonstrating a decrease in thickness for each site, separating skin and subcutaneous changes, on the affected limb via Ultrasound
Outcome measures
| Measure |
Flexitouch Plus
n=1 Participants
Flexitouch Plus: Flexitouch Plus full arm and core treatment
|
Flexitouch Plus With SW
n=1 Participants
Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
|
|---|---|---|
|
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
Skin Thickness (Site C)
|
0 Percent of Participants
|
100 Percent of Participants
|
|
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
Subcutaneous Thickness (Site A)
|
0 Percent of Participants
|
100 Percent of Participants
|
|
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
Skin Thickness (Site A)
|
100 Percent of Participants
|
100 Percent of Participants
|
|
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
Skin Thickness (Site B)
|
0 Percent of Participants
|
100 Percent of Participants
|
|
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
Subcutaneous Thickness (Site B)
|
0 Percent of Participants
|
0 Percent of Participants
|
|
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
Subcutaneous Thickness (Site C)
|
100 Percent of Participants
|
0 Percent of Participants
|
PRIMARY outcome
Timeframe: Baseline and following a single treatment, an average of one hour.Skin Changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Outcome measures
| Measure |
Flexitouch Plus
n=1 Participants
Flexitouch Plus: Flexitouch Plus full arm and core treatment
|
Flexitouch Plus With SW
n=1 Participants
Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment
|
|---|---|---|
|
Absolute Change in Skin Thickness From Baseline to After Treatment
Affected Limb Absolute Change
|
-1.70 mm
Interval -8.25 to 0.11
|
-0.03 mm
Interval -1.18 to 0.6
|
|
Absolute Change in Skin Thickness From Baseline to After Treatment
Contralateral Limb Absolute Change
|
-0.52 mm
Interval -1.86 to 0.31
|
-1.54 mm
Interval -6.44 to 0.04
|
Adverse Events
Flexitouch Plus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Flexitouch Plus With SW
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER