Head and Neck NeoplasmsNCT03332160
A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment
A study testing Flexitouch head and neck lymphedema treatment system and Standard home lymphedema care in people with Head and Neck Neoplasms and Head and Neck Cancer, run by Tactile Medical at 2 sites in United States.
Trial summary
The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Lymphedema
- What is being tested?
- Flexitouch head and neck lymphedema treatment system and Standard home lymphedema care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2018to 31 Jul 2019
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years.
- A previous diagnosis of histologically defined head and neck cancer.
- A diagnosis of head and neck lymphedema.
- Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation.
- Completed cancer treatment with no evidence of active cancer; all post-surgical swelling must be resolved.
- The head and neck garments must fit appropriately. For patients with a tracheostomy, the fit will be assessed to ensure that the garments do not interfere with their tracheostomy.
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- The subject must have experienced at least one of the following:
- Completion of phase 1 lymphedema care in the past 8 weeks;
- The inability to participate/complete phase 1 care due to:
- Lack of available therapist/clinic,
- Lack of insurance coverage or funding to support cost of care.
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, acute or within 3 months.
- Increased intracranial pressure or other contraindications to internal or external jugular venous compression.
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- Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), 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.
- History of pulmonary edema or decompensated congestive heart failure with in six (6) week of enrollment.
- Subject is pregnant or trying to become pregnant.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt University
Nashville, Tennessee, 37240
SIU School of Medicine
Springfield, Illinois, 62702
About this study
The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone.
Read the detailed description
This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. The study will be conducted at up to 2 sites in the United States and enroll 40 subjects with a diagnosis of head and neck lymphedema following treatment for head and neck cancer. Subjects randomized to receive daily treatment with the Flexitouch pneumatic compression device and home care regimen (SOC) will be seen at baseline and weeks 1, 4, and 8. Subjects randomized to the wait list arm will be seen at baseline and weeks 1, 4, and 8 while receiving SOC treatment. Assessments will include fidelity, satisfaction, symptoms, swelling/inflammation, function, and QOL.
- Being tested
- Flexitouch head and neck lymphedema treatment system, Standard home lymphedema care
- Keywords
- Lymphedema, Cancer, Head Cancer, Neck Cancer, Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms, Lymphedema, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexitouch head and neck lymphedema treatment systemDevice
Also called Flexitouch System
Pneumatic compression device cleared for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as: lymphedema; primary lymphedema; post mastectomy edema; edema following trauma and sports injuries; post immobilization edema; venous insufficiency; reducing wound healing time; treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers. The Flexitouch system and garments for head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.
Standard home lymphedema careOther
May include daily self manual lymphatic drainage, exercise, skin care, compression garments (as appropriate).
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard home lymphedema care Receives: Other: Standard home lymphedema care |
| Flexitouch head and neck lymphedema treatment system | Experimental | Daily treatment with Flexitouch® pneumatic compression device for treatment of head and neck lymphedema and standard home lymphedema care Receives: Device: Flexitouch head and neck lymphedema treatment system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity/Adherence Via Subject Diary
Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring fidelity/adherence using a subject diary. Values represent a count of participants who met the prescribed use criteria by week. The prescribed use was defined as two 30 minute sessions in a day.
Measured: From baseline to end of treatment at 8 weeks
Adverse Events
Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring adverse events using the CTCAE (v4.0). Values represent the count of events per adverse events category.
Measured: From baseline to the end of treatment at 8 weeks
Treatment Satisfaction
Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring treatment satisfaction using a satisfaction survey. A survey assessed participants' perceived ability to control their head and neck lymphedema before (at baseline) and after the usage of the Flexitouch at 8 weeks. Values represent a count of participants who indicated good, very good, or excellent.
Measured: From baseline to the end of treatment at 8 weeks
Secondary outcomes (11)
Reduction in Swelling/Inflammation - Endoscopy
The change in percent of sites with visible swelling and inflammation as assessed via endoscopy (using Modified Patterson Scale) from baseline to week 8. The range for each anatomical structure includes 1-4: Normal, Mild, Moderate, and Severe. A lower score means a better outcome. A greater negative value indicates a greater reduction in swelling. Total score range: 0-100%.
Measured: From baseline to the end of treatment at 8 weeks
Reduction in Swelling/Inflammation - Cytokine Levels
The presence of swelling and inflammation was assessed in all participants via the change in cytokine levels of Interleukin 6 (IL-6) at baseline to week 8. A lower score means a better outcome. A greater negative value indicates a greater reduction in cytokine levels.
Measured: From baseline to the end of treatment at 8 weeks
Reduction in Swelling/Inflammation - Digital Photography
The presence of swelling and inflammation was assessed in all participants by digital photography at baseline and 8 weeks. A lower value means a better outcome. A greater negative value indicates a greater reduction in swelling. Three views were scored each with 30 grids. The percentage of views with visible swelling was determined. The score ranged from 0-100%.
Measured: From baseline to the end of treatment at 8 weeks
Reduction in Swelling/Inflammation - Grading of External Lymphedema
The presence of swelling and inflammation was assessed in all participants through grading of external lymphedema via the Head and Neck Lymphedema and Fibrosis Assessment criteria (HNLEF) during a physical examination at baseline and 8 weeks. A total of 9 sites were evaluated for the presence of lymphedema and graded from 1 (mild) to 3 (severe) at each site. The number of sites ranged from 0-9 with a total severity score ranging from 0-27. Results are the change in a total score between baseline and 8 weeks. A lower score indicates a better outcome. A greater negative value indicates a greater reduction in swelling.
Measured: From baseline to the end of treatment at 8 weeks
Function - Jaw Range of Motion
The function was assessed in all participants at baseline and week 8 through the jaw range of motion measurements using the Therabite Jaw ROM Scale. The TheraBite Jaw ROM Scale was used to measure in millimeters the jaw opening of the maximum inter-incisal distance (upper right central to lower right central incisor). The values were categorized by grade change. The change of -1 indicates the severity improved by one grade. A value of zero indicates a participant remained stable. A value of 1 indicates a patient worsened by one grade.
Measured: From baseline to the end of treatment at 8 weeks
Function - Neck Disability Index
The function was assessed in all participants at baseline and week 8 by the Neck Disability Index (NDI). Values represent a change from baseline. Minimum score: 0 with a minimum disability of 0%. Maximum score: 50 with a maximal disability of 100%.
0 - 20% (minimal) - The patient can cope with most living activities. Usually, no treatment is indicated apart from advice on lifting sitting and exercise.
21 - 40% (moderate) - The patient experiences more pain and difficulty with sitting lifting and standing. Travel and social life are more difficult and they may be disabled from work. The patient can usually be managed by conservative means.
41 - 60% (severe) -Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation.
61 - 80% (crippled) - Pain impinges on all aspects of the patient's life. Positive intervention is required.
81 - 100% (bed bound) - Need to exclude exaggeration or malingering.
Measured: From baseline to the end of treatment at 8 weeks
Function - Voice Handicap Index
The function was assessed in all participants at baseline and week 8 by the Voice Handicap Index (VHI). Values represent a change from baseline. Max / Min Total Score: 0-120. A lower score indicates a better outcome.
Measured: From baseline to the end of treatment at 8 weeks
Function - Cervical and Shoulder Range of Motion
The function was assessed in all participants at baseline and week 8 through the cervical range of motion (CROM) and shoulder range of motion (SROM) measurements. A positive value indicates a better outcome. The greater the value, the greater the change from baseline.
Measured: From baseline to the end of treatment at 8 weeks
Symptoms - Vanderbilt Head and Neck Symptom Survey
Symptoms were assessed in all participants at baseline and week 8 via the Vanderbilt Head and Neck Symptom Survey plus General Symptom Survey (VHNSS v2.0 plus GSS). Values represent a median score change from baseline. Score range: 0-10. A lower score indicates a better outcome. A more negative value indicates a greater change from baseline. Given this was a self-reported survey, responses were not mandatory and thus missing for some subjects.
Measured: From baseline to the end of treatment at 8 weeks
Quality of Life - Linear Analog Self-Assessment
Quality of life was assessed in all participants at baseline and week 8 using the Linear Analog Self-Assessment. The total score for the assessment ranged from 0-50. Each category represents a change in score from the baseline visit which ranged from positive 4 to negative 4. A positive change indicates an improvement. Values represent the count of participants in each category.
Measured: From baseline to the end of treatment at 8 weeks
Symptoms - Lymphedema Symptom Intensity and Distress Survey
Lymphedema Symptom Intensity and Distress Survey-Head and Neck (LSIDS-HN) assessed the measurement characteristics of a symptom burden for participants with head and neck lymphedema at baseline and week 8. Each symptom was rated on intensity and distress using a 5-point scale. A maximum response for any symptom within a given cluster was used for the analysis. The total score ranged from 0-10. The values represent a change from baseline. A lower score means a better outcome.
Measured: From baseline to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start2 Jan 2018
- Primary completion4 Jun 2019
- Study completion31 Jul 2019
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 NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tactile Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University
- Responsible party
- Sponsor
- Investigators
- Sheila Ridner, PhD, RN, Principal investigator, Vanderbilt University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332160
- Sponsor's protocol ID
- 4030
- Status last verified
- Jul 2020
- First submitted
- 24 Oct 2017
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment
- ClinicalTrials.gov ID
- NCT03332160
- Acronym / sponsor ID
- 4030
- Keywords
- Lymphedema, Cancer, Head Cancer, Neck Cancer, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Tactile MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 6 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone.
Detailed description
This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. The study will be conducted at up to 2 sites in the United States and enroll 40 subjects with a diagnosis of head and neck lymphedema following treatment for head and neck cancer. Subjects randomized to receive daily treatment with the Flexitouch pneumatic compression device and home care regimen (SOC) will be seen at baseline and weeks 1, 4, and 8. Subjects randomized to the wait list arm will be seen at baseline and weeks 1, 4, and 8 while receiving SOC treatment. Assessments will include fidelity, satisfaction, symptoms, swelling/inflammation, function, and QOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard home lymphedema careStandard home lymphedema care |
| Flexitouch head and neck lymphedema treatment system | Experimental | Device: Flexitouch head and neck lymphedema treatment systemDaily treatment with Flexitouch® pneumatic compression device for treatment of head and neck lymphedema and standard home lymphedema care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years.
- A previous diagnosis of histologically defined head and neck cancer.
- A diagnosis of head and neck lymphedema.
- Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation.
- Completed cancer treatment with no evidence of active cancer; all post-surgical swelling must be resolved.
Key exclusion criteria (12 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, acute or 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 head and neck lymphedema treatment systemAlso: Flexitouch SystemPneumatic compression device cleared for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as: lymphedema; primary lymphedema; post mastectomy edema; edema following trauma and sports injuries; post immobilization edema; venous insufficiency; reducing wound healing time; treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers. The Flexitouch system and garments for head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema. | Device | Flexitouch head and neck lymphedema treatment system |
| Standard home lymphedema careMay include daily self manual lymphatic drainage, exercise, skin care, compression garments (as appropriate). | Other | Standard of Care |
Primary outcome
Fidelity/Adherence Via Subject Diary
Time frame: From baseline to end of treatment at 8 weeks
Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring fidelity/adherence using a subject diary. Values represent a count of participants who met the prescribed use criteria by week. The prescribed use was defined as two 30 minute sessions in a day.
Adverse Events
Time frame: From baseline to the end of treatment at 8 weeks
Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring adverse events using the CTCAE (v4.0). Values represent the count of events per adverse events category.
Treatment Satisfaction
Time frame: From baseline to the end of treatment at 8 weeks
Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring treatment satisfaction using a satisfaction survey. A survey assessed participants' perceived ability to control their head and neck lymphedema before (at baseline) and after the usage of the Flexitouch at 8 weeks. Values represent a count of participants who indicated good, very good, or excellent.
11 secondary outcomes
Reduction in Swelling/Inflammation - Endoscopy
Time frame: From baseline to the end of treatment at 8 weeks
Reduction in Swelling/Inflammation - Cytokine Levels
Time frame: From baseline to the end of treatment at 8 weeks
Reduction in Swelling/Inflammation - Digital Photography
Time frame: From baseline to the end of treatment at 8 weeks
Reduction in Swelling/Inflammation - Grading of External Lymphedema
Time frame: From baseline to the end of treatment at 8 weeks
Function - Jaw Range of Motion
Time frame: From baseline to the end of treatment at 8 weeks
Function - Neck Disability Index
Time frame: From baseline to the end of treatment at 8 weeks
Function - Voice Handicap Index
Time frame: From baseline to the end of treatment at 8 weeks
Function - Cervical and Shoulder Range of Motion
Time frame: From baseline to the end of treatment at 8 weeks
Symptoms - Vanderbilt Head and Neck Symptom Survey
Time frame: From baseline to the end of treatment at 8 weeks
Quality of Life - Linear Analog Self-Assessment
Time frame: From baseline to the end of treatment at 8 weeks
Symptoms - Lymphedema Symptom Intensity and Distress Survey
Time frame: From baseline to the end of treatment at 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sheila Ridner, PhD, RN principal investigator
Vanderbilt University School of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexitouch head and neck lymphedema treatment system and Standard home lymphedema care in people with Head and Neck Neoplasms and Head and Neck Cancer, run by Tactile Medical at 2 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 11 inclusion and 12 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: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 6 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?
Fidelity/Adherence Via Subject Diary (time frame: From baseline to end of treatment at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2020.