Trial Outcomes & Findings for A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema (NCT NCT03558672)

NCT ID: NCT03558672

Last Updated: 2020-09-02

Results Overview

To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in symptoms/problems. Negative value shows a decrease in symptoms/problems. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.

• Recruitment status: TERMINATED
• Target enrollment: 18 participants
• Primary outcome timeframe: Percent Changes between Baseline and 6 months will be assessed
• Results posted on: 2020-09-02

Participant Flow

Participants were recruited among therapists and physicians across 4 US sites between September 2018 and March 2020. The first subject was enrolled on September 14, 2018.

Participant milestones

Measure	Intervention Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
Overall Study STARTED	18
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	Intervention Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
Overall Study Study Early Termination	10

Baseline Characteristics

A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema

Baseline characteristics by cohort

Measure	Intervention n=18 Participants Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
Age, Continuous	62.1 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race/Ethnicity, Customized Race : White or Caucasian	17 participants n=5 Participants
Race/Ethnicity, Customized Race : Black or African American	1 participants n=5 Participants
Race/Ethnicity, Customized Race : Asian	0 participants n=5 Participants
Race/Ethnicity, Customized Race : American Indian or Alaska Native	2 participants n=5 Participants
Race/Ethnicity, Customized Race : Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants
Race/Ethnicity, Customized Race : Other	0 participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Hispanic or Latino	1 participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Not Hispanic or Latino	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Percent Changes between Baseline and 6 months will be assessed

Population: Although 8 participants had completed the study, only 7 completed all required questionnaires. Therefore, the analysis population only includes the 7 participants who completed the required questionnaires throughout the study.

To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus.

Positive value shows an increase in symptoms/problems. Negative value shows a decrease in symptoms/problems. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.

Outcome measures

Measure	Intervention n=7 Participants Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
Symptom/Problem Improvement From Baseline to 6 Months Have you had pain in your mouth?	14.3 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had pain in your jaw?	30.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had soreness in your mouth?	17.4 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had a painful throat?	35.3 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had problems swallowing liquids?	23.5 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had problems swallowing pureed food?	53.8 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had problems swallowing solid food?	-7.7 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you choked when swallowing?	-20.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had problems with your teeth?	30.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had problems opening your mouth wide?	13.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had a dry mouth?	0.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had sticky saliva?	4.3 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had problems with you sense of smell?	-5.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had problems with your sense of taste?	3.4 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you coughed?	-4.2 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you been hoarse?	0.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you felt ill?	0.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Has your appearance bothered you?	-20.8 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had trouble eating?	0.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had trouble eating in front of family?	17.6 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had trouble eating in front of people?	-22.2 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had trouble enjoying your meals?	3.8 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had trouble talking to other people?	-4.8 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had trouble talking on the telephone?	-17.4 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had trouble social contact with family?	-29.4 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had trouble social contact with friends?	-19.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had trouble going out in public?	-23.8 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you had trouble having physical contact?	-35.3 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you felt less interest in sex?	0.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you felt less sexual enjoyment?	-14.8 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you used pain killers?	28.6 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you taken any nutritional supplements?	50.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you used a feeding tube?	-50.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you lost weight?	-20.0 percent change in score
Symptom/Problem Improvement From Baseline to 6 Months Have you gained weight?	57.1 percent change in score

PRIMARY outcome

Timeframe: Percent Changes between Baseline and 6 months will be assessed

Population: Analysis includes the 8 participants who completed the study required visits and assessments.

To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus.

Positive value shows an increase in Function/Range of Motion. Negative value shows a decrease in Function/Range of Motion. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline.

Outcome measures

Measure	Intervention n=8 Participants Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
Function (Range of Motion) Improvement From Baseline to 6 Months Cervical: Flexion	3.7 percent change in measurement
Function (Range of Motion) Improvement From Baseline to 6 Months Cervical: Extension	28.9 percent change in measurement
Function (Range of Motion) Improvement From Baseline to 6 Months Cervical: Right Lateral	1.5 percent change in measurement
Function (Range of Motion) Improvement From Baseline to 6 Months Cervical: Left Lateral	15.9 percent change in measurement
Function (Range of Motion) Improvement From Baseline to 6 Months Cervical: Right Rotation	28.5 percent change in measurement
Function (Range of Motion) Improvement From Baseline to 6 Months Cervical: Left Rotation	7.8 percent change in measurement
Function (Range of Motion) Improvement From Baseline to 6 Months Shoulder: Right Flexion	-2.0 percent change in measurement
Function (Range of Motion) Improvement From Baseline to 6 Months Shoulder: Right Abduction	12.6 percent change in measurement
Function (Range of Motion) Improvement From Baseline to 6 Months Shoulder: Left Flexion	-1.9 percent change in measurement
Function (Range of Motion) Improvement From Baseline to 6 Months Shoulder: Left Abduction	2.6 percent change in measurement
Function (Range of Motion) Improvement From Baseline to 6 Months Mouth: Open	0.6 percent change in measurement

SECONDARY outcome

Timeframe: Percent Changes between Baseline and 6 months will be assessed

Population: Although 8 participants had completed the study, only 7 completed all required questionnaires. Therefore, the analysis population only includes the 7 participants who completed the required questionnaires throughout the study.

Subject Quality of Life will be assessed using EORTC C30 questionnaire. Positive value shows an decrease in quality of life. Negative value shows a increase in quality of life. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.

Outcome measures

Measure	Intervention n=7 Participants Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
Changes in Health-related Quality of Life From Baseline to 6 Months Do you have trouble doing strenuous activities?	-17.2 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Do you have any trouble taking a long walk?	0.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Do you have trouble taking a short walk?	-12.5 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Do you need to stay in bed or a chair during day?	0.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Do you need help eating, dressing, washing?	40.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Were you limited in work or other day activities?	4.3 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Were you limited in hobbies or leisure activities?	8.3 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Were you short of breath?	6.3 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Have you had pain?	0.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Did you need to rest?	21.1 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Have you had trouble sleeping?	-12.5 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Have you felt weak?	0.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Have you lacked appetite?	5.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Have you felt nauseated?	10.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Have you vomited?	0.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Have you been constipated?	-18.8 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Have you had diarrhea?	7.1 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Were you tired?	0.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Did pain interfere with daily activities?	0.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Have you had difficulty concentrating?	-5.9 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Did you feel tense?	0.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Did you worry?	10.5 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Did you feel Irritable?	0.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Did you feel depressed?	25.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Have you had difficulty remembering things?	0.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Has condition/treatment interfered with family?	-18.2 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Has condition/treatment interfered socially?	0.0 percent change in score
Changes in Health-related Quality of Life From Baseline to 6 Months Has condition/treatment caused difficult finances?	-4.8 percent change in score

SECONDARY outcome

Timeframe: Percent Changes between Baseline and 6 months will be assessed

Population: Although 8 participants had completed the study, only 7 completed all required questionnaires. Therefore, the analysis population only includes the 7 participants who completed the required questionnaires throughout the study.

Subject overall health and quality of life in the past week-EORTC C30. Positive value shows an increase in quality of life/overall health. Negative value shows a decrease in quality of life/overall health. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.

Outcome measures

Measure	Intervention n=7 Participants Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
Changes in Health-related Quality of Life-Overall From Baseline to 6 Months Overall health during the past week	4.3 % change from baseline to 6 months
Changes in Health-related Quality of Life-Overall From Baseline to 6 Months Overall quality of life during the past week	0.0 % change from baseline to 6 months

SECONDARY outcome

Timeframe: Percent Changes between Baseline and 6 months will be assessed

Population: Although 8 participants had completed the study, only 7 completed all required questionnaires. Therefore, the analysis population only includes the 7 participants who completed the required questionnaires throughout the study.

Pain will be assessed using the VAS Pain Scale. Positive value shows an increase in pain. Negative value shows a decrease in pain. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.

Outcome measures

Measure	Intervention n=7 Participants Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
Changes in Pain From Baseline to 6 Months	47.5 percent change in score

SECONDARY outcome

Timeframe: Percent Changes between Baseline and 6 months will be assessed

Population: Analysis includes the 8 participants who completed the study required visits and assessments.

Swelling will be assessed using the ALOHA measurement protocol. Positive value shows an increase in swelling. Negative value shows a decrease in swelling. Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline.

Outcome measures

Measure	Intervention n=8 Participants Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
Change in Swelling From Baseline to 6 Months Lower Neck Circumference	-3.0 percent change in swelling measurements
Change in Swelling From Baseline to 6 Months Upper Neck Circumference	-2.1 percent change in swelling measurements
Change in Swelling From Baseline to 6 Months Ear to Ear Length	-2.6 percent change in swelling measurements

SECONDARY outcome

Timeframe: Assessed at 6 months

Population: Although 8 participants had completed the study, only 7 completed all required questionnaires. Therefore, the analysis population only includes the 7 participants who completed the required questionnaires throughout the study.

Both Ease of Use/Satisfaction will be assessed by survey. Percentage of each response captured.

Outcome measures

Measure	Intervention n=7 Participants Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
Ease of Use/Satisfaction Very comfortable treatment by Flexitouch system	42.9 percent of participants
Ease of Use/Satisfaction Very difficult to use Flexitouch garments	0.0 percent of participants
Ease of Use/Satisfaction Difficult to use Flexitouch garments	0.0 percent of participants
Ease of Use/Satisfaction Neither easy nor difficult with Flexitouch garment	14.3 percent of participants
Ease of Use/Satisfaction Easy to use Flexitouch garments	57.1 percent of participants
Ease of Use/Satisfaction Very easy to use Flexitouch garments	28.6 percent of participants
Ease of Use/Satisfaction Very difficult to use Flexitouch controller	0.0 percent of participants
Ease of Use/Satisfaction Difficult to use Flexitouch controller	0.0 percent of participants
Ease of Use/Satisfaction Neither easy nor difficult-Flexitouch controller	0.0 percent of participants
Ease of Use/Satisfaction Easy to use Flexitouch controller	42.9 percent of participants
Ease of Use/Satisfaction Very easy to use Flexitouch controller	57.1 percent of participants
Ease of Use/Satisfaction Very uncomfortable treatment by Flexitouch system	0.0 percent of participants
Ease of Use/Satisfaction Uncomfortable treatment by Flexitouch system	0.0 percent of participants
Ease of Use/Satisfaction Neither uncomfortable nor comfortable treatment	0.0 percent of participants
Ease of Use/Satisfaction Comfortable treatment by Flexitouch system	57.1 percent of participants
Ease of Use/Satisfaction Very dissatisfied overall with Flexitouch system	0.0 percent of participants
Ease of Use/Satisfaction Dissatisfied overall with Flexitouch system	0.0 percent of participants
Ease of Use/Satisfaction Neither dissatisfied nor satisfied overall	0.0 percent of participants
Ease of Use/Satisfaction Satisfied overall with Flexitouch system	28.6 percent of participants
Ease of Use/Satisfaction Very satisfied overall with Flexitouch system	71.4 percent of participants
Ease of Use/Satisfaction Yes, would recommend Flexitouch system to others	100 percent of participants
Ease of Use/Satisfaction No,would not recommend Flexitouch system to others	0.0 percent of participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention n=18 participants at risk Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cyst	5.6% 1/18 • Number of events 1 • Adverse events were collected on participants who received and were trained on the device from the 2 week visit until 6 month visit or study exit.
Skin and subcutaneous tissue disorders Dry Skin	5.6% 1/18 • Number of events 1 • Adverse events were collected on participants who received and were trained on the device from the 2 week visit until 6 month visit or study exit.
Cardiac disorders Hypotension	5.6% 1/18 • Number of events 1 • Adverse events were collected on participants who received and were trained on the device from the 2 week visit until 6 month visit or study exit.
Skin and subcutaneous tissue disorders Lingual villosa	5.6% 1/18 • Number of events 1 • Adverse events were collected on participants who received and were trained on the device from the 2 week visit until 6 month visit or study exit.
Musculoskeletal and connective tissue disorders Osteomylelitis	5.6% 1/18 • Number of events 1 • Adverse events were collected on participants who received and were trained on the device from the 2 week visit until 6 month visit or study exit.
Skin and subcutaneous tissue disorders Rash	5.6% 1/18 • Number of events 1 • Adverse events were collected on participants who received and were trained on the device from the 2 week visit until 6 month visit or study exit.

Additional Information

Director of Clinical Research

Tactile Medical

Phone: 612.540.5267

Email: astone@tactilemedical.com

Results disclosure agreements

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

Restriction type: LTE60