Head and Neck Cancer, Head and Neck Lymphedema, Head and Neck Neoplasms
Conditions
Keywords
Lymphedema, Cancer, Head Cancer, Neck Cancer, Head and Neck Cancer
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.
Interventions
DEVICEFlexitouch head and neck lymphedema treatment 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.
OTHERStandard home lymphedema care
May include daily self manual lymphatic drainage, exercise, skin care, compression garments (as appropriate).
Sponsors
Vanderbilt University
Tactile Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity/Adherence Via Subject Diary | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Swelling/Inflammation - Grading of External Lymphedema | From baseline to the end of treatment at 8 weeks | 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. |
| Function - Jaw Range of Motion | From baseline to the end of treatment at 8 weeks | 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. |
| Function - Neck Disability Index | From baseline to the end of treatment at 8 weeks | 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. |
| Function - Voice Handicap Index | From baseline to the end of treatment at 8 weeks | 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. |
| Reduction in Swelling/Inflammation - Endoscopy | From baseline to the end of treatment at 8 weeks | 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%. |
| Symptoms - Vanderbilt Head and Neck Symptom Survey | From baseline to the end of treatment at 8 weeks | 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. |
| Quality of Life - Linear Analog Self-Assessment | From baseline to the end of treatment at 8 weeks | 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. |
| Symptoms - Lymphedema Symptom Intensity and Distress Survey | From baseline to the end of treatment at 8 weeks | 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. |
| Function - Cervical and Shoulder Range of Motion | From baseline to the end of treatment at 8 weeks | 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. |
| Reduction in Swelling/Inflammation - Cytokine Levels | From baseline to the end of treatment at 8 weeks | 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. |
| Reduction in Swelling/Inflammation - Digital Photography | From baseline to the end of treatment at 8 weeks | 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%. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wait-list Control Group Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate) | 24 |
| Interventional Group Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable | 19 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Developed Exclusion Criteria | 0 | 1 |
| Overall Study | Non-adherence to treatment | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Interventional Group | Total | Wait-list Control Group |
|---|---|---|---|
| Age, Continuous | 61.1 years | 62.2 years | 62.8 years |
| Alcohol history/current | 14 Participants | 32 Participants | 18 Participants |
| Body Mass Index (BMI) at Enrollment Normal/Health Weight | 2 Participants | 7 Participants | 5 Participants |
| Body Mass Index (BMI) at Enrollment Obese | 8 Participants | 16 Participants | 8 Participants |
| Body Mass Index (BMI) at Enrollment Overweight | 8 Participants | 18 Participants | 10 Participants |
| Body Mass Index (BMI) at Enrollment Underweight | 1 Participants | 2 Participants | 1 Participants |
| Education Advance Degree | 5 Participants | 6 Participants | 1 Participants |
| Education College | 8 Participants | 21 Participants | 13 Participants |
| Education <=High School | 6 Participants | 16 Participants | 10 Participants |
| Marital Status Married/Living with Partner | 17 Participants | 37 Participants | 20 Participants |
| Marital Status Other | 2 Participants | 6 Participants | 4 Participants |
| Months since Initial Lymphedema Treatment | 4.5 months | 4.6 months | 4.6 months |
| Months since Lymphedema Diagnosis | 5.2 months | 5.2 months | 5.3 months |
| Percutaneous Endoscopic Gastrostomy (PEG) at Enrollment | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 42 Participants | 24 Participants |
| Region of Enrollment United States | 19 participants | 43 participants | 24 participants |
| Residence City | 7 Participants | 15 Participants | 8 Participants |
| Residence Country | 6 Participants | 18 Participants | 12 Participants |
| Residence Suburb | 6 Participants | 10 Participants | 4 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 15 Participants | 35 Participants | 20 Participants |
| Smoking history/current | 12 Participants | 28 Participants | 16 Participants |
| Tracheotomy at Enrollment | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 24 | 0 / 19 |
| other Total, other adverse events | 20 / 24 | 14 / 19 |
| serious Total, serious adverse events | 2 / 24 | 2 / 19 |
Outcome results
Primary
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.
Time frame: From baseline to the end of treatment at 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Interventional Group | Adverse Events | Cardiac disorders | 3 Events |
| Interventional Group | Adverse Events | Ear and labyrinth disorders | 1 Events |
| Interventional Group | Adverse Events | Endocrine disorders | 2 Events |
| Interventional Group | Adverse Events | Eye disorders | 1 Events |
| Interventional Group | Adverse Events | Gastrointestinal disorders | 3 Events |
| Interventional Group | Adverse Events | General disorders | 7 Events |
| Interventional Group | Adverse Events | Immune system disorders | 1 Events |
| Interventional Group | Adverse Events | Infections and infestations | 7 Events |
| Interventional Group | Adverse Events | Musculoskeletal and connective tissue disorders | 0 Events |
| Interventional Group | Adverse Events | Neoplasms benign, malignant and unspecified | 1 Events |
| Interventional Group | Adverse Events | Nervous system disorders | 6 Events |
| Interventional Group | Adverse Events | Psychiatric disorders | 2 Events |
| Interventional Group | Adverse Events | Skin and subcutaneous tissue disorders | 5 Events |
| Interventional Group | Adverse Events | Respiratory, thoracic and mediastinal disorders | 10 Events |
| Interventional Group | Adverse Events | Vascular disorders | 3 Events |
| Interventional Group | Adverse Events | Surgical and medical procedures | 1 Events |
| Interventional Group | Adverse Events | Musculoskeletal and connective tissue disorders | 2 Events |
| Interventional Group | Adverse Events | Cardiac disorders | 0 Events |
| Interventional Group | Adverse Events | Surgical and medical procedures | 3 Events |
| Interventional Group | Adverse Events | Ear and labyrinth disorders | 1 Events |
| Interventional Group | Adverse Events | Neoplasms benign, malignant and unspecified | 0 Events |
| Interventional Group | Adverse Events | Endocrine disorders | 2 Events |
| Interventional Group | Adverse Events | Vascular disorders | 1 Events |
| Interventional Group | Adverse Events | Nervous system disorders | 7 Events |
| Interventional Group | Adverse Events | Gastrointestinal disorders | 3 Events |
| Interventional Group | Adverse Events | Respiratory, thoracic and mediastinal disorders | 5 Events |
| Interventional Group | Adverse Events | General disorders | 2 Events |
| Interventional Group | Adverse Events | Psychiatric disorders | 0 Events |
| Interventional Group | Adverse Events | Immune system disorders | 0 Events |
| Interventional Group | Adverse Events | Eye disorders | 0 Events |
| Interventional Group | Adverse Events | Infections and infestations | 1 Events |
| Interventional Group | Adverse Events | Skin and subcutaneous tissue disorders | 1 Events |
Primary
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.
Time frame: From baseline to end of treatment at 8 weeks
Population: This analysis only applies to the Interventional Group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 1 | 3 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 1 | 0 days | 5 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 1 | 1 day | 1 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 1 | 2 days | 1 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 1 | 4 days | 1 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 1 | 5 days | 3 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 1 | 6 days | 1 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 1 | 7 days | 5 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 2 | 0 days | 4 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 2 | 1 day | 1 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 2 | 2 days | 0 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 2 | 3 days | 1 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 2 | 4 days | 4 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 2 | 5 days | 3 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 2 | 6 days | 1 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 2 | 7 days | 5 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 3 | 0 days | 4 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 3 | 1 day | 0 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 3 | 2 days | 1 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 3 | 3 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 3 | 4 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 3 | 5 days | 4 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 3 | 6 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 3 | 7 days | 4 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 4 | 0 days | 3 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 4 | 1 day | 1 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 4 | 2 days | 3 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 4 | 3 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 4 | 4 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 4 | 5 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 4 | 6 days | 3 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 4 | 7 days | 3 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 5 | 0 days | 4 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 5 | 1 day | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 5 | 2 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 5 | 3 days | 0 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 5 | 4 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 5 | 5 days | 5 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 5 | 6 days | 1 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 5 | 7 days | 3 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 6 | 0 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 6 | 1 day | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 6 | 2 days | 0 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 6 | 3 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 6 | 4 days | 4 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 6 | 5 days | 3 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 6 | 6 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 6 | 7 days | 4 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 7 | 0 days | 3 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 7 | 1 day | 1 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 7 | 2 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 7 | 3 days | 3 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 7 | 4 days | 1 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 7 | 5 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 7 | 6 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 7 | 7 days | 5 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 8 | 0 days | 4 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 8 | 1 day | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 8 | 2 days | 3 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 8 | 3 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 8 | 4 days | 4 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 8 | 5 days | 1 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 8 | 6 days | 2 Participants |
| Interventional Group | Fidelity/Adherence Via Subject Diary | Week 8 | 7 days | 1 Participants |
Primary
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.
Time frame: From baseline to the end of treatment at 8 weeks
Population: This only applied to participants in the interventional group who had indicated good, very good, or excellent in regards to their perceived ability to control their head and neck lymphedema.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional Group | Treatment Satisfaction | Baseline (Good, Very Good, or Excellent) | 5 Participants |
| Interventional Group | Treatment Satisfaction | 8 Weeks (Good, Very Good, or Excellent) | 16 Participants |
Secondary
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.
Time frame: From baseline to the end of treatment at 8 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Interventional Group | Function - Cervical and Shoulder Range of Motion | CROM Forward Flexion | -1.00 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | CROM Extension | 4.00 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | CROM Left Lateral Rotation | -1.00 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | CROM Right Lateral Rotation | -0.50 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | SROM Forward Flexion (Right Active) | 0.00 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | SROM Forward Flexion (Left Active) | -0.75 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | SROM Abduction (Right Active) | 7.00 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | SROM Abduction (Left Active) | 5.50 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | SROM External Rotation (Right Active) | -1.25 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | SROM External Rotation (Left Active) | -2.25 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | SROM Abduction (Left Active) | 5.00 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | CROM Forward Flexion | -2.00 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | SROM Forward Flexion (Left Active) | 7.50 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | CROM Extension | 1.00 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | SROM External Rotation (Left Active) | 2.50 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | CROM Left Lateral Rotation | -1.00 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | SROM Abduction (Right Active) | 3.00 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | CROM Right Lateral Rotation | 1.00 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | SROM External Rotation (Right Active) | 0.00 Degrees |
| Interventional Group | Function - Cervical and Shoulder Range of Motion | SROM Forward Flexion (Right Active) | 1.50 Degrees |
Secondary
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.
Time frame: From baseline to the end of treatment at 8 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional Group | Function - Jaw Range of Motion | -1 | 4 Participants |
| Interventional Group | Function - Jaw Range of Motion | 0 | 18 Participants |
| Interventional Group | Function - Jaw Range of Motion | 1 | 2 Participants |
| Interventional Group | Function - Jaw Range of Motion | -1 | 1 Participants |
| Interventional Group | Function - Jaw Range of Motion | 0 | 17 Participants |
| Interventional Group | Function - Jaw Range of Motion | 1 | 1 Participants |
Secondary
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.
Time frame: From baseline to the end of treatment at 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Group | Function - Neck Disability Index | 1.00 score on a scale |
| Interventional Group | Function - Neck Disability Index | 0.00 score on a scale |
Secondary
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.
Time frame: From baseline to the end of treatment at 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Group | Function - Voice Handicap Index | 0.50 score on a scale |
| Interventional Group | Function - Voice Handicap Index | 0.00 score on a scale |
Secondary
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.
Time frame: From baseline to the end of treatment at 8 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | -1 | 5 Participants |
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | 1 | 4 Participants |
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | -2 | 1 Participants |
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | 2 | 2 Participants |
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | 0 | 10 Participants |
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | 4 | 1 Participants |
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | -4 | 1 Participants |
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | 4 | 0 Participants |
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | -4 | 0 Participants |
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | -2 | 0 Participants |
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | -1 | 3 Participants |
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | 0 | 13 Participants |
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | 1 | 2 Participants |
| Interventional Group | Quality of Life - Linear Analog Self-Assessment | 2 | 1 Participants |
Secondary
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.
Time frame: From baseline to the end of treatment at 8 weeks
Population: Not all participants' blood samples were analyzable.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Group | Reduction in Swelling/Inflammation - Cytokine Levels | -836.47 fg/ml |
| Interventional Group | Reduction in Swelling/Inflammation - Cytokine Levels | -275.68 fg/ml |
Secondary
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%.
Time frame: From baseline to the end of treatment at 8 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Interventional Group | Reduction in Swelling/Inflammation - Digital Photography | Front View Change | 4.924 score on a scale |
| Interventional Group | Reduction in Swelling/Inflammation - Digital Photography | Right View Change | -7.279 score on a scale |
| Interventional Group | Reduction in Swelling/Inflammation - Digital Photography | Left View Change | -4.4466 score on a scale |
| Interventional Group | Reduction in Swelling/Inflammation - Digital Photography | Front View Change | -24.308 score on a scale |
| Interventional Group | Reduction in Swelling/Inflammation - Digital Photography | Right View Change | -22.368 score on a scale |
| Interventional Group | Reduction in Swelling/Inflammation - Digital Photography | Left View Change | -16.5217 score on a scale |
Secondary
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%.
Time frame: From baseline to the end of treatment at 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Group | Reduction in Swelling/Inflammation - Endoscopy | -2.7778 Change in score |
| Interventional Group | Reduction in Swelling/Inflammation - Endoscopy | -11.1111 Change in score |
Secondary
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.
Time frame: From baseline to the end of treatment at 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Group | Reduction in Swelling/Inflammation - Grading of External Lymphedema | -0.5000 score on a scale |
| Interventional Group | Reduction in Swelling/Inflammation - Grading of External Lymphedema | 0.0000 score on a scale |
Secondary
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.
Time frame: From baseline to the end of treatment at 8 weeks
Population: Data may be missing or left blank by participant.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Soft Tissue | 0.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Neurological | 0.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Oral | 0.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | BioBehavioral | 0.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Resources | 0.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Sexuality | 0.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Activity | 0.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Function | 0.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Function | 0.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Soft Tissue | -2.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Resources | 0.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Neurological | 0.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Activity | 0.0 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Oral | 0.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | Sexuality | 0.00 score on a scale |
| Interventional Group | Symptoms - Lymphedema Symptom Intensity and Distress Survey | BioBehavioral | 0.00 score on a scale |
Secondary
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.
Time frame: From baseline to the end of treatment at 8 weeks
Population: Data was not available and/or applicable to all participants in certain categories.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Mouth Pain | 0.00 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | General Pain | 0.67 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Swallowing Solids | -0.06 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Swallowing Liquids | 0.00 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Nutrition | 0.00 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Mucous | -0.12 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Dry Mouth | 0.20 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Taste/Smell | -0.25 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Voice | -0.67 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Teeth | 0.25 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Taste/Smell | -0.17 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Mouth Pain | 0.00 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Mucous | -0.50 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | General Pain | 0.00 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Teeth | 0.00 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Swallowing Solids | -0.25 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Dry Mouth | 0.00 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Swallowing Liquids | 0.00 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Voice | -.033 score on a scale |
| Interventional Group | Symptoms - Vanderbilt Head and Neck Symptom Survey | Nutrition | 0.00 score on a scale |