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

Terminated

• Conditions: Head and Neck Lymphedema

• Registration Number: NCT03558672
• Lead Sponsor: Tactile Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-10
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-15
• Study Start: 2018-09-14
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Results First Submitted: 2020-06-12
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-06
• Results First Posted: 2020-08-18
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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 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.
Ease of Use/Satisfaction	Assessed at 6 months	Both Ease of Use/Satisfaction will be assessed by survey. Percentage of each response captured.

Trial Locations

Locations (4)

Iowa ENT Center; 🇺🇸 West Des Moines, Iowa, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Charles George VA Medical Center; 🇺🇸 Asheville, North Carolina, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States