Head and Neck Lymphedema
Conditions
Keywords
Flexitouch
Brief summary
The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events.
Interventions
DEVICEFlexitouch system with Head and Neck Garments
Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed
Sponsors
Tactile Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * A diagnosis of head and/or neck lymphedema * Must be able and willing to participate in all aspects of the registry and provide informed consent prior to registry participation * Head and chest measurements within the following: * Crown of head circumference: ≤ 72 cm * Chest circumference: ≤ 158 cm * Prescribed the Flexitouch system or Flexitouch Plus
Exclusion criteria
* Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression) * Carotid sinus hypersensitivity syndrome * Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness) * Symptomatic bradycardia in the absence of a pacemaker * Internal jugular venous thrombosis (within 3 months) * Increased intracranial pressure or other contraindications to internal or external jugular venous compression * Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), or surgical flap less than 6-8 weeks post-operative * Facial or head and neck dermal metastasis * Acute facial infection (e.g., facial or parotid gland abscess) * Any condition in which increased venous and lymphatic return is undesirable * Heart failure (acute pulmonary edema, decompensated acute heart failure) * Subject is pregnant or trying to become pregnant * Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom/Problem Improvement From Baseline to 6 Months | Percent Changes between Baseline and 6 months will be assessed | 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. |
| Function (Range of Motion) Improvement From Baseline to 6 Months | Percent Changes between Baseline and 6 months will be assessed | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Pain From Baseline to 6 Months | Percent Changes between Baseline and 6 months will be assessed | 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. |
| Changes in Health-related Quality of Life From Baseline to 6 Months | Percent Changes between Baseline and 6 months will be assessed | 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. |
| Ease of Use/Satisfaction | Assessed at 6 months | Both Ease of Use/Satisfaction will be assessed by survey. Percentage of each response captured. |
| Change in Swelling From Baseline to 6 Months | Percent Changes between Baseline and 6 months will be assessed | 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. |
| Changes in Health-related Quality of Life-Overall From Baseline to 6 Months | Percent Changes between Baseline and 6 months will be assessed | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Early Termination | 10 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 62.1 years |
| Race/Ethnicity, Customized Ethnicity: Hispanic or Latino | 1 participants |
| Race/Ethnicity, Customized Ethnicity: Not Hispanic or Latino | 17 participants |
| Race/Ethnicity, Customized Race : American Indian or Alaska Native | 2 participants |
| Race/Ethnicity, Customized Race : Asian | 0 participants |
| Race/Ethnicity, Customized Race : Black or African American | 1 participants |
| Race/Ethnicity, Customized Race : Native Hawaiian or Other Pacific Islander | 0 participants |
| Race/Ethnicity, Customized Race : Other | 0 participants |
| Race/Ethnicity, Customized Race : White or Caucasian | 17 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 3 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Function (Range of Motion) Improvement From Baseline to 6 Months
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.
Time frame: Percent Changes between Baseline and 6 months will be assessed
Population: Analysis includes the 8 participants who completed the study required visits and assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Function (Range of Motion) Improvement From Baseline to 6 Months | Shoulder: Right Flexion | -2.0 percent change in measurement |
| Intervention | Function (Range of Motion) Improvement From Baseline to 6 Months | Cervical: Flexion | 3.7 percent change in measurement |
| Intervention | Function (Range of Motion) Improvement From Baseline to 6 Months | Cervical: Extension | 28.9 percent change in measurement |
| Intervention | Function (Range of Motion) Improvement From Baseline to 6 Months | Cervical: Right Lateral | 1.5 percent change in measurement |
| Intervention | Function (Range of Motion) Improvement From Baseline to 6 Months | Cervical: Left Lateral | 15.9 percent change in measurement |
| Intervention | Function (Range of Motion) Improvement From Baseline to 6 Months | Cervical: Right Rotation | 28.5 percent change in measurement |
| Intervention | Function (Range of Motion) Improvement From Baseline to 6 Months | Cervical: Left Rotation | 7.8 percent change in measurement |
| Intervention | Function (Range of Motion) Improvement From Baseline to 6 Months | Shoulder: Right Abduction | 12.6 percent change in measurement |
| Intervention | Function (Range of Motion) Improvement From Baseline to 6 Months | Shoulder: Left Flexion | -1.9 percent change in measurement |
| Intervention | Function (Range of Motion) Improvement From Baseline to 6 Months | Shoulder: Left Abduction | 2.6 percent change in measurement |
| Intervention | Function (Range of Motion) Improvement From Baseline to 6 Months | Mouth: Open | 0.6 percent change in measurement |
Primary
Symptom/Problem Improvement From Baseline to 6 Months
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had pain in your mouth? | 14.3 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had pain in your jaw? | 30.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had soreness in your mouth? | 17.4 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had a painful throat? | 35.3 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had problems swallowing liquids? | 23.5 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had problems swallowing pureed food? | 53.8 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had problems swallowing solid food? | -7.7 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you choked when swallowing? | -20.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had problems with your teeth? | 30.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had problems opening your mouth wide? | 13.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had a dry mouth? | 0.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had sticky saliva? | 4.3 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had problems with you sense of smell? | -5.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had problems with your sense of taste? | 3.4 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you coughed? | -4.2 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you been hoarse? | 0.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you felt ill? | 0.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Has your appearance bothered you? | -20.8 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had trouble eating? | 0.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had trouble eating in front of family? | 17.6 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had trouble eating in front of people? | -22.2 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had trouble enjoying your meals? | 3.8 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had trouble talking to other people? | -4.8 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had trouble talking on the telephone? | -17.4 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had trouble social contact with family? | -29.4 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had trouble social contact with friends? | -19.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had trouble going out in public? | -23.8 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you had trouble having physical contact? | -35.3 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you felt less interest in sex? | 0.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you felt less sexual enjoyment? | -14.8 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you used pain killers? | 28.6 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you taken any nutritional supplements? | 50.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you used a feeding tube? | -50.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you lost weight? | -20.0 percent change in score |
| Intervention | Symptom/Problem Improvement From Baseline to 6 Months | Have you gained weight? | 57.1 percent change in score |
Secondary
Change in Swelling From Baseline to 6 Months
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.
Time frame: Percent Changes between Baseline and 6 months will be assessed
Population: Analysis includes the 8 participants who completed the study required visits and assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Change in Swelling From Baseline to 6 Months | Lower Neck Circumference | -3.0 percent change in swelling measurements |
| Intervention | Change in Swelling From Baseline to 6 Months | Upper Neck Circumference | -2.1 percent change in swelling measurements |
| Intervention | Change in Swelling From Baseline to 6 Months | Ear to Ear Length | -2.6 percent change in swelling measurements |
Secondary
Changes in Health-related Quality of Life From Baseline to 6 Months
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Did you need to rest? | 21.1 percent change in score |
| Intervention | 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 |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Were you short of breath? | 6.3 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Have you had pain? | 0.0 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Have you felt weak? | 0.0 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Have you lacked appetite? | 5.0 percent change in score |
| Intervention | 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 |
| Intervention | 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 |
| Intervention | 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 |
| Intervention | 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 |
| Intervention | 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 |
| Intervention | 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 |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Have you had trouble sleeping? | -12.5 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Have you felt nauseated? | 10.0 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Have you vomited? | 0.0 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Have you been constipated? | -18.8 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Have you had diarrhea? | 7.1 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Were you tired? | 0.0 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Did pain interfere with daily activities? | 0.0 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Have you had difficulty concentrating? | -5.9 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Did you feel tense? | 0.0 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Did you worry? | 10.5 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Did you feel Irritable? | 0.0 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Did you feel depressed? | 25.0 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Have you had difficulty remembering things? | 0.0 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Has condition/treatment interfered with family? | -18.2 percent change in score |
| Intervention | Changes in Health-related Quality of Life From Baseline to 6 Months | Has condition/treatment interfered socially? | 0.0 percent change in score |
| Intervention | 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
Changes in Health-related Quality of Life-Overall From Baseline to 6 Months
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | 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 |
| Intervention | 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
Changes in Pain From Baseline to 6 Months
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Changes in Pain From Baseline to 6 Months | 47.5 percent change in score |
Secondary
Ease of Use/Satisfaction
Both Ease of Use/Satisfaction will be assessed by survey. Percentage of each response captured.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Ease of Use/Satisfaction | Easy to use Flexitouch controller | 42.9 percent of participants |
| Intervention | Ease of Use/Satisfaction | Very difficult to use Flexitouch garments | 0.0 percent of participants |
| Intervention | Ease of Use/Satisfaction | Difficult to use Flexitouch garments | 0.0 percent of participants |
| Intervention | Ease of Use/Satisfaction | Neither easy nor difficult with Flexitouch garment | 14.3 percent of participants |
| Intervention | Ease of Use/Satisfaction | Easy to use Flexitouch garments | 57.1 percent of participants |
| Intervention | Ease of Use/Satisfaction | Very easy to use Flexitouch garments | 28.6 percent of participants |
| Intervention | Ease of Use/Satisfaction | Very difficult to use Flexitouch controller | 0.0 percent of participants |
| Intervention | Ease of Use/Satisfaction | Difficult to use Flexitouch controller | 0.0 percent of participants |
| Intervention | Ease of Use/Satisfaction | Neither easy nor difficult-Flexitouch controller | 0.0 percent of participants |
| Intervention | Ease of Use/Satisfaction | Very easy to use Flexitouch controller | 57.1 percent of participants |
| Intervention | Ease of Use/Satisfaction | Very uncomfortable treatment by Flexitouch system | 0.0 percent of participants |
| Intervention | Ease of Use/Satisfaction | Uncomfortable treatment by Flexitouch system | 0.0 percent of participants |
| Intervention | Ease of Use/Satisfaction | Neither uncomfortable nor comfortable treatment | 0.0 percent of participants |
| Intervention | Ease of Use/Satisfaction | Comfortable treatment by Flexitouch system | 57.1 percent of participants |
| Intervention | Ease of Use/Satisfaction | Very comfortable treatment by Flexitouch system | 42.9 percent of participants |
| Intervention | Ease of Use/Satisfaction | Very dissatisfied overall with Flexitouch system | 0.0 percent of participants |
| Intervention | Ease of Use/Satisfaction | Dissatisfied overall with Flexitouch system | 0.0 percent of participants |
| Intervention | Ease of Use/Satisfaction | Neither dissatisfied nor satisfied overall | 0.0 percent of participants |
| Intervention | Ease of Use/Satisfaction | Satisfied overall with Flexitouch system | 28.6 percent of participants |
| Intervention | Ease of Use/Satisfaction | Very satisfied overall with Flexitouch system | 71.4 percent of participants |
| Intervention | Ease of Use/Satisfaction | Yes, would recommend Flexitouch system to others | 100 percent of participants |
| Intervention | Ease of Use/Satisfaction | No,would not recommend Flexitouch system to others | 0.0 percent of participants |