Head and Neck LymphedemaNCT03558672

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

An observational study of Head and Neck Lymphedema, run by Tactile Medical at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Head and Neck Lymphedema
What is being tested?: Flexitouch system with Head and Neck Garments
Type of treatment: Medical device
How many people: 18 participants
Where: 4 sitesUnited States
Study dates: 14 Sep 2018to 1 May 2020
How long will I take part?: 6 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Charles George VA Medical Center
Asheville, North Carolina, 28805
The Ohio State University
Columbus, Ohio, 43210
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Iowa ENT Center
West Des Moines, Iowa, 50265

Other trials in United States

About this study

Conditions: Head and Neck Lymphedema
Being tested: Flexitouch system with Head and Neck Garments
Keywords: Flexitouch

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Flexitouch system with Head and Neck GarmentsDevice
Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Percent Changes between Baseline and 6 months will be assessed
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.
Measured: Percent Changes between Baseline and 6 months will be assessed

Secondary outcomes (5)

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.
Measured: Percent Changes between Baseline and 6 months will be assessed
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.
Measured: Percent Changes between Baseline and 6 months will be assessed
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.
Measured: Percent Changes between Baseline and 6 months will be assessed
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.
Measured: Percent Changes between Baseline and 6 months will be assessed
Ease of Use/Satisfaction
Both Ease of Use/Satisfaction will be assessed by survey. Percentage of each response captured.
Measured: Assessed at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 20181 May 2020

First posted15 Jun 2018
Study start14 Sep 2018
Primary completion1 May 2020
Study completion1 May 2020

Why it stopped: Low enrollment numbers

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Head and Neck LymphedemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 18 participants (actual)
Target duration: 6 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT03558672
Sponsor's protocol ID: 4060
Status last verified: Aug 2020
First submitted: 10 May 2018
Last updated: 2 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Preventing Lymphedema in Patients Undergoing Surgical Treatment for Head and Neck Cancer Through Vein Reconstruction
Head and Neck Cancer
Not yet recruiting
Evaluation of Adherence to Rehabilitation: Autonomous and Guided, in the Observation and Treatment Response of Head and Neck Lymphedema in Neoplasms During Radiotherapy
Lymphedema, Head and Neck Neoplasms
Recruiting
Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
Lymphedema of the Head and Neck
Active, not recruitingPhase 1
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship
Lymphedema of Face, Head and Neck Cancer
RecruitingPhase 2
Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)
Fibrosis Syndrome, Lymphedema

All Head and Neck Lymphedema trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema
ClinicalTrials.gov ID: NCT03558672
Acronym / sponsor ID: 4060
Conditions: Head and Neck Lymphedema
Keywords: Flexitouch
Study type: Observational
Recruitment status: TerminatedReason stopped: Low enrollment numbers
Enrolment: 18 participants (actual)
Lead sponsor: Tactile MedicalIndustry (pharma, biotech, devices)
Study start: 14 Sep 2018 (actual)
Primary completion: 1 May 2020 (actual)
Study completion: 1 May 2020 (actual)
First posted: 15 Jun 2018 (actual)
Results: Posted 18 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 6 Months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment

Key inclusion criteria (7 listed)

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

Key exclusion criteria (13 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Flexitouch system with Head and Neck GarmentsFlexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed	Device	–

Primary outcome

Symptom/Problem Improvement From Baseline to 6 Months
Time frame: 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
Time frame: 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.

5 secondary outcomes

Changes in Health-related Quality of Life From Baseline to 6 Months
Time frame: Percent Changes between Baseline and 6 months will be assessed
Changes in Health-related Quality of Life-Overall From Baseline to 6 Months
Time frame: Percent Changes between Baseline and 6 months will be assessed
Changes in Pain From Baseline to 6 Months
Time frame: Percent Changes between Baseline and 6 months will be assessed
Change in Swelling From Baseline to 6 Months
Time frame: Percent Changes between Baseline and 6 months will be assessed
Ease of Use/Satisfaction
Time frame: Assessed at 6 months

Results and safety

Results posted to the registry on 18 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	18	8

Primary outcome: Symptom/Problem Improvement From Baseline to 6 Months

Time frame: Percent Changes between Baseline and 6 months will be assessed. Number. Unit: percent change in score

Measure	Intervention n = 7
Have you had pain in your mouth?	14.3
Have you had pain in your jaw?	30.0
Have you had soreness in your mouth?	17.4
Have you had a painful throat?	35.3
Have you had problems swallowing liquids?	23.5
Have you had problems swallowing pureed food?	53.8
Have you had problems swallowing solid food?	-7.7
Have you choked when swallowing?	-20.0

Population analysed: 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.

Primary outcome: Function (Range of Motion) Improvement From Baseline to 6 Months

Time frame: Percent Changes between Baseline and 6 months will be assessed. Number. Unit: percent change in measurement

Measure	Intervention n = 8
Cervical: Flexion	3.7
Cervical: Extension	28.9
Cervical: Right Lateral	1.5
Cervical: Left Lateral	15.9
Cervical: Right Rotation	28.5
Cervical: Left Rotation	7.8
Shoulder: Right Flexion	-2.0
Shoulder: Right Abduction	12.6

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

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 18 (0%)	3 of 18 (16.7%)	0 of 18

Limitations and caveats (from the sponsor): This study was prematurely terminated in regards to slow enrollment; there were no safety issues presented. The variability in the small N (N=8) provide inconclusive evidence and non analyzable outcome measure from this incomplete data cohort.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Head and Neck Lymphedema

Recruiting
Preventing Lymphedema in Patients Undergoing Surgical Treatment for Head and Neck Cancer Through Vein Reconstruction
Head and Neck Cancer
Not yet recruiting
Evaluation of Adherence to Rehabilitation: Autonomous and Guided, in the Observation and Treatment Response of Head and Neck Lymphedema in Neoplasms During Radiotherapy
Lymphedema, Head and Neck Neoplasms
Recruiting
Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
Lymphedema of the Head and Neck
Active, not recruitingPhase 1
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship
Lymphedema of Face, Head and Neck Cancer
RecruitingPhase 2
Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)
Fibrosis Syndrome, Lymphedema

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Lymphedema, run by Tactile Medical at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom/Problem Improvement From Baseline to 6 Months (time frame: Percent Changes between Baseline and 6 months will be assessed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03558672.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.