A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment

Conditions
-----------------
Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Lymphedema

Intervention / Treatment
-----------------
* Device: Flexitouch head and neck lymphedema treatment system
* Other: Standard home lymphedema care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. 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. 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, acute or 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), 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Standard home lymphedema care | Other: Standard home lymphedema care<br>* May include daily self manual lymphatic drainage, exercise, skin care, compression garments (as appropriate).<br>|
| Experimental: Flexitouch head and neck lymphedema treatment system<br>Daily treatment with Flexitouch® pneumatic compression device for treatment of head and neck lymphedema and standard home lymphedema care | Device: Flexitouch head and neck lymphedema treatment system<br>* 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.<br>* Other names: Flexitouch System;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | From baseline to the end of treatment at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%. | 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. | 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%. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From baseline to the end of treatment at 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphedema, Cancer, Head Cancer, Neck Cancer, Head and Neck Cancer