Trial Outcomes & Findings for Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema. (NCT NCT04432727)

NCT ID: NCT04432727

Last Updated: 2023-05-24

Results Overview

Compare the rate of compliance in patients treated with PASSIVE FT-CC and ACTIVE FT-CC.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: 60 Days
• Results posted on: 2023-05-24

Participant Flow

Participant milestones

Measure	ACTIVE FT-CC Text message reminders will be sent if subject does not use the device for 2 consecutive days. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC	PASSIVE FT-CC Text message reminders will not be sent to subjects. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC
Overall Study STARTED	15	14
Overall Study COMPLETED	14	11
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.

Baseline characteristics by cohort

Measure	ACTIVE FT-CC n=15 Participants Text message reminders will be sent if subject does not use the device for 2 consecutive days. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC	PASSIVE FT-CC n=14 Participants Text message reminders will not be sent to subjects. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC	Total n=29 Participants Total of all reporting groups
Age, Continuous	52.3 years STANDARD_DEVIATION 10.8 • n=5 Participants	57.7 years STANDARD_DEVIATION 9.7 • n=7 Participants	54.9 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	14 Participants n=7 Participants	29 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	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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
Region of Enrollment United States	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Weight	190.9 pounds STANDARD_DEVIATION 42.8 • n=5 Participants	179.1 pounds STANDARD_DEVIATION 42.0 • n=7 Participants	185.2 pounds STANDARD_DEVIATION 42.1 • n=5 Participants
Height	63.8 inches STANDARD_DEVIATION 2.3 • n=5 Participants	62.4 inches STANDARD_DEVIATION 1.6 • n=7 Participants	63.1 inches STANDARD_DEVIATION 2.1 • n=5 Participants
BMI	33.1 kg/m^2 STANDARD_DEVIATION 8.0 • n=5 Participants	32.4 kg/m^2 STANDARD_DEVIATION 7.4 • n=7 Participants	32.8 kg/m^2 STANDARD_DEVIATION 7.6 • n=5 Participants
Dominant Hand Left	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Dominant Hand Right	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 Days

Population: Patients who received text reminders vs. those that did not.

Compare the rate of compliance in patients treated with PASSIVE FT-CC and ACTIVE FT-CC.

Outcome measures

Measure	ACTIVE FT-CC n=15 Participants Text message reminders will be sent if subject does not use the device for 2 consecutive days. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC	PASSIVE FT-CC n=14 Participants Text message reminders will not be sent to subjects. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC
Compliance Measured as the Average Number of Treatments Per Week	5.3 treatments/week Standard Deviation 1.8	5.2 treatments/week Standard Deviation 2.1

SECONDARY outcome

Timeframe: Through 60 days after device training

Population: Subjects who were also seen 60 days post randomization.

Analysis of compliance with prescribed device use.

Outcome measures

Measure	ACTIVE FT-CC n=13 Participants Text message reminders will be sent if subject does not use the device for 2 consecutive days. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC	PASSIVE FT-CC n=10 Participants Text message reminders will not be sent to subjects. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC
Compliance With Device Use. Non-Compliant (<1 Day / Week)	0 Participants	1 Participants
Compliance With Device Use. Partially Compliant (1-4 Days / Week)	6 Participants	4 Participants
Compliance With Device Use. Compliant (5-7 Days / Week)	7 Participants	5 Participants

SECONDARY outcome

Timeframe: Changes through 60 days after device training

Population: Subjects completing the LYMQOL-ARM Tool at 60 days overall quality of life score 0-10 scale.

Comparison of quality of life in patients treated with Active FT-CC vs. Passive FT-CC via Lymphedema Quality of Life Tool (LYMQOL ARM).

Lymphedema Quality of Life Tool (LYMQOL-ARM) includes sub-scores for Function (range 10-40), Appearance (range 5-20), Symptoms (range 6-24), and Emotion (range 6-24) where lower scores represent a better outcome. It also includes an Overall QOL sub-score (range 0-10) where a higher score represents a better outcome.

Outcome measures

Measure	ACTIVE FT-CC n=14 Participants Text message reminders will be sent if subject does not use the device for 2 consecutive days. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC	PASSIVE FT-CC n=11 Participants Text message reminders will not be sent to subjects. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC
Quality of Life Assessment Via LYMQOL ARM	7.6 score on a scale Standard Deviation 2.0	6.6 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Changes through 60 days after device training

Population: Patients with data through 60 days after device training. An increase in score reflects a positive outcome.

Comparison of baseline vs. 60-day follow-up results of the The RAND 36-Item Short Form Survey (SF-36).

The RAND 36-Item Short Form Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item for perceived change in health. Min value: 0, Max value: 100. Higher scores represent a better outcome.

Outcome measures

Measure	ACTIVE FT-CC n=14 Participants Text message reminders will be sent if subject does not use the device for 2 consecutive days. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC	PASSIVE FT-CC n=11 Participants Text message reminders will not be sent to subjects. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC
Quality of Life Assessment Via SF-36 Physical Functioning Domain Score Decrease in general health domain scores at 60 days	4 Participants	8 Participants
Quality of Life Assessment Via SF-36 Physical Functioning Domain Score No change in general health domain scores at 60 days	4 Participants	0 Participants
Quality of Life Assessment Via SF-36 Physical Functioning Domain Score Increase in general health domain score change at 60 days	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Changes through 60 days after device training

Population: All patients with follow-up through 60 days completing the LSIDS-A Questionnaire. A reduction in overall domain score change is considered to be positive.

Comparison of baseline vs. 60-day follow-up results of the LSIDS-A Scoring Tool.

The LSIDS-A domains consist of 30 questions in the areas of soft tissue sensation, neurological sensation, function, behavior, resource, sexuality, and activity. Scores are compiled by domain and overall. Overall results will be posted here.

Outcome measures

Measure	ACTIVE FT-CC n=13 Participants Text message reminders will be sent if subject does not use the device for 2 consecutive days. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC	PASSIVE FT-CC n=11 Participants Text message reminders will not be sent to subjects. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC
Quality of Life Assessment Via LSIDS-A Score Decrease in domain score change at 60 days	12 Participants	8 Participants
Quality of Life Assessment Via LSIDS-A Score No change in domain score at 60 days	0 Participants	0 Participants
Quality of Life Assessment Via LSIDS-A Score Increase in domain score change at 60 days.	1 Participants	3 Participants

Adverse Events

ACTIVE FT-CC

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PASSIVE FT-CC

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	ACTIVE FT-CC n=15 participants at risk Text message reminders will be sent if subject does not use the device for 2 consecutive days. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC	PASSIVE FT-CC n=14 participants at risk Text message reminders will not be sent to subjects. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC
Infections and infestations Acute pyelonephritis	0.00% 0/15 • Adverse event data were collected from the point of randomization through study exit (Day 60).	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).

Other adverse events

Measure	ACTIVE FT-CC n=15 participants at risk Text message reminders will be sent if subject does not use the device for 2 consecutive days. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC	PASSIVE FT-CC n=14 participants at risk Text message reminders will not be sent to subjects. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC
Musculoskeletal and connective tissue disorders Clicking in right thumb joint	0.00% 0/15 • Adverse event data were collected from the point of randomization through study exit (Day 60).	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).
Musculoskeletal and connective tissue disorders Bilateral buttock pain	0.00% 0/15 • Adverse event data were collected from the point of randomization through study exit (Day 60).	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).
Musculoskeletal and connective tissue disorders Exacerbation of lymphedema related pain right arm	0.00% 0/15 • Adverse event data were collected from the point of randomization through study exit (Day 60).	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).
Infections and infestations Suspected cellulitis	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).	0.00% 0/14 • Adverse event data were collected from the point of randomization through study exit (Day 60).
Injury, poisoning and procedural complications Trauma secondary to fall	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).	0.00% 0/14 • Adverse event data were collected from the point of randomization through study exit (Day 60).
Blood and lymphatic system disorders Lymphedema exacerbation	0.00% 0/15 • Adverse event data were collected from the point of randomization through study exit (Day 60).	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).
Blood and lymphatic system disorders Progressive disease right axilla	0.00% 0/15 • Adverse event data were collected from the point of randomization through study exit (Day 60).	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).
Skin and subcutaneous tissue disorders Swelling under right arm due to weight gain, no lymphedema	0.00% 0/15 • Adverse event data were collected from the point of randomization through study exit (Day 60).	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).
Respiratory, thoracic and mediastinal disorders Bronchitis	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).	0.00% 0/14 • Adverse event data were collected from the point of randomization through study exit (Day 60).
Infections and infestations Sinus infection	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).	0.00% 0/14 • Adverse event data were collected from the point of randomization through study exit (Day 60).
Respiratory, thoracic and mediastinal disorders Increased lung nodule from 2011	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).	0.00% 0/14 • Adverse event data were collected from the point of randomization through study exit (Day 60).
Skin and subcutaneous tissue disorders Tender in armpit when using device	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).	0.00% 0/14 • Adverse event data were collected from the point of randomization through study exit (Day 60).
Blood and lymphatic system disorders Worsening lymphedema (mild)	0.00% 0/15 • Adverse event data were collected from the point of randomization through study exit (Day 60).	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).
Skin and subcutaneous tissue disorders Maculo-papular rash	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the point of randomization through study exit (Day 60).	0.00% 0/14 • Adverse event data were collected from the point of randomization through study exit (Day 60).

Additional Information

Michelle Wetherby

Tactile Medical

Phone: 612-230-4576

Email: mwetherby@tactilemedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60