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

• Sponsor: Tactile Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03332160
• Collaborator: Vanderbilt University (Other)
• Enrollment: 49
• Locations: 2
• Arms: 2
• Actual Duration (Months): 18.9
• Patients Per Site: 24.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Neoplasms; Head and Neck Cancer; Head and Neck Lymphedema	Device: Flexitouch head and neck lymphedema treatment system; Other: Standard home lymphedema care	N/A

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

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment
• Actual Study Start Date: Jan 2, 2018
• Actual Primary Completion Date: Jun 4, 2019
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of Care Standard home lymphedema care	Other: Standard home lymphedema care; May include daily self manual lymphatic drainage, exercise, skin care, compression garments (as appropriate).
Experimental: Flexitouch head and neck lymphedema treatment system 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; 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.; Other Names: Flexitouch System

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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 Outcome Measures

1. 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%.

2. 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.

3. 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%.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SIU School of Medicine	Springfield	Illinois	United States	62702
2	Vanderbilt University	Nashville	Tennessee	United States	37240

Sponsors and Collaborators

• Tactile Medical
• Vanderbilt University

Investigators

• Principal Investigator: Sheila Ridner, PhD, RN, Vanderbilt University School of Nursing

Study Documents (Full-Text)

• Informed Consent Form - Nov 7, 2017
• Study Protocol and Statistical Analysis Plan - Sep 26, 2017

More Information

Publications

None provided.

• Responsible Party: Tactile Medical
• ClinicalTrials.gov Identifier: NCT03332160
• Other Study ID Numbers: 4030
• First Posted: Nov 6, 2017
• Last Update Posted: Aug 6, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Tactile Medical: Lymphedema; Cancer; Head Cancer; Neck Cancer; Head and Neck Cancer
• Additional relevant MeSH terms: Head and Neck Neoplasms; Lymphedema

Study Results

Participant Flow

Arm/Group Title	Wait-list Control Group	Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage (MLD), exercise, skincare, compression garments (as appropriate)	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
Period Title: Overall Study
STARTED	25	24
COMPLETED	24	19
NOT COMPLETED	1	5

Baseline Characteristics

Arm/Group Title	Wait-list Control Group	Interventional Group	Total
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate)	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	Total of all reporting groups
Overall Participants	24	19	43
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	62.8	61.1	62.2
Sex: Female, Male (Count of Participants)
Female	4 16.7%	4 21.1%	8 18.6%
Male	20 83.3%	15 78.9%	35 81.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	24 100%	18 94.7%	42 97.7%
More than one race	0 0%	1 5.3%	1 2.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	24 100%	19 100%	43 100%
Education (Count of Participants)
<=High School	10 41.7%	6 31.6%	16 37.2%
College	13 54.2%	8 42.1%	21 48.8%
Advance Degree	1 4.2%	5 26.3%	6 14%
Marital Status (Count of Participants)
Married/Living with Partner	20 83.3%	17 89.5%	37 86%
Other	4 16.7%	2 10.5%	6 14%
Residence (Count of Participants)
City	8 33.3%	7 36.8%	15 34.9%
Country	12 50%	6 31.6%	18 41.9%
Suburb	4 16.7%	6 31.6%	10 23.3%
Body Mass Index (BMI) at Enrollment (Count of Participants)
Underweight	1 4.2%	1 5.3%	2 4.7%
Normal/Health Weight	5 20.8%	2 10.5%	7 16.3%
Overweight	10 41.7%	8 42.1%	18 41.9%
Obese	8 33.3%	8 42.1%	16 37.2%
Smoking history/current (Count of Participants)
Count of Participants [Participants]	16 66.7%	12 63.2%	28 65.1%
Alcohol history/current (Count of Participants)
Count of Participants [Participants]	18 75%	14 73.7%	32 74.4%
Tracheotomy at Enrollment (Count of Participants)
Count of Participants [Participants]	4 16.7%	2 10.5%	6 14%
Percutaneous Endoscopic Gastrostomy (PEG) at Enrollment (Count of Participants)
Count of Participants [Participants]	6 25%	6 31.6%	12 27.9%
Months since Lymphedema Diagnosis (months) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [months]	5.3	5.2	5.2
Months since Initial Lymphedema Treatment (months) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [months]	4.6	4.5	4.6

Outcome Measures

1. Primary Outcome

Title	Fidelity/Adherence Via Subject Diary
Description	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

Outcome Measure Data

Analysis Population Description

This analysis only applies to the Interventional Group.

Arm/Group Title	Interventional Group
Arm/Group Description	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.
Measure Participants	19
0 days	5 20.8%
1 day	1 4.2%
2 days	1 4.2%
3 days	2 8.3%
4 days	1 4.2%
5 days	3 12.5%
6 days	1 4.2%
7 days	5 20.8%
0 days	4 16.7%
1 day	1 4.2%
2 days	0 0%
3 days	1 4.2%
4 days	4 16.7%
5 days	3 12.5%
6 days	1 4.2%
7 days	5 20.8%
0 days	4 16.7%
1 day	0 0%
2 days	1 4.2%
3 days	2 8.3%
4 days	2 8.3%
5 days	4 16.7%
6 days	2 8.3%
7 days	4 16.7%
0 days	3 12.5%
1 day	1 4.2%
2 days	3 12.5%
3 days	2 8.3%
4 days	2 8.3%
5 days	2 8.3%
6 days	3 12.5%
7 days	3 12.5%
0 days	4 16.7%
1 day	2 8.3%
2 days	2 8.3%
3 days	0 0%
4 days	2 8.3%
5 days	5 20.8%
6 days	1 4.2%
7 days	3 12.5%
0 days	2 8.3%
1 day	2 8.3%
2 days	0 0%
3 days	2 8.3%
4 days	4 16.7%
5 days	3 12.5%
6 days	2 8.3%
7 days	4 16.7%
0 days	3 12.5%
1 day	1 4.2%
2 days	2 8.3%
3 days	3 12.5%
4 days	1 4.2%
5 days	2 8.3%
6 days	2 8.3%
7 days	5 20.8%
0 days	4 16.7%
1 day	2 8.3%
2 days	3 12.5%
3 days	2 8.3%
4 days	4 16.7%
5 days	1 4.2%
6 days	2 8.3%
7 days	1 4.2%

2. Primary Outcome

Title	Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wait-list Control Group	Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).	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.
Measure Participants	24	19
Cardiac disorders	3	0
Ear and labyrinth disorders	1	1
Endocrine disorders	2	2
Eye disorders	1	0
Gastrointestinal disorders	3	3
General disorders	7	2
Immune system disorders	1	0
Infections and infestations	7	1
Musculoskeletal and connective tissue disorders	0	2
Neoplasms benign, malignant and unspecified	1	0
Nervous system disorders	6	7
Psychiatric disorders	2	0
Skin and subcutaneous tissue disorders	5	1
Surgical and medical procedures	1	3
Respiratory, thoracic and mediastinal disorders	10	5
Vascular disorders	3	1

3. Primary Outcome

Title	Treatment Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Interventional Group
Arm/Group Description	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.
Measure Participants	19
Baseline (Good, Very Good, or Excellent)	5 20.8%
8 Weeks (Good, Very Good, or Excellent)	16 66.7%

4. Secondary Outcome

Title	Reduction in Swelling/Inflammation - Endoscopy
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wait-list Control Group	Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).	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.
Measure Participants	24	19
Median (Inter-Quartile Range) [Change in score]	-2.7778	-11.1111

5. Secondary Outcome

Title	Reduction in Swelling/Inflammation - Cytokine Levels
Description	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

Outcome Measure Data

Analysis Population Description

Not all participants' blood samples were analyzable.

Arm/Group Title	Wait-list Control Group	Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).	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.
Measure Participants	20	18
Median (Inter-Quartile Range) [fg/ml]	-836.47	-275.68

6. Secondary Outcome

Title	Reduction in Swelling/Inflammation - Digital Photography
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wait-list Control Group	Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).	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.
Measure Participants	24	19
Front View Change	4.924	-24.308
Right View Change	-7.279	-22.368
Left View Change	-4.4466	-16.5217

7. Secondary Outcome

Title	Reduction in Swelling/Inflammation - Grading of External Lymphedema
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wait-list Control Group	Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).	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.
Measure Participants	24	19
Median (Inter-Quartile Range) [score on a scale]	-0.5000	0.0000

8. Secondary Outcome

Title	Function - Jaw Range of Motion
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wait-list Control Group	Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).	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.
Measure Participants	24	19
-1	4 16.7%	1 5.3%
0	18 75%	17 89.5%
1	2 8.3%	1 5.3%

9. Secondary Outcome

Title	Function - Neck Disability Index
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wait-list Control Group	Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).	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.
Measure Participants	24	19
Median (Inter-Quartile Range) [score on a scale]	1.00	0.00

10. Secondary Outcome

Title	Function - Voice Handicap Index
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wait-list Control Group	Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).	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.
Measure Participants	24	19
Median (Inter-Quartile Range) [score on a scale]	0.50	0.00

11. Secondary Outcome

Title	Function - Cervical and Shoulder Range of Motion
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wait-list Control Group	Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).	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.
Measure Participants	24	19
CROM Forward Flexion	-1.00	-2.00
CROM Extension	4.00	1.00
CROM Left Lateral Rotation	-1.00	-1.00
CROM Right Lateral Rotation	-0.50	1.00
SROM Forward Flexion (Right Active)	0.00	1.50
SROM Forward Flexion (Left Active)	-0.75	7.50
SROM Abduction (Right Active)	7.00	3.00
SROM Abduction (Left Active)	5.50	5.00
SROM External Rotation (Right Active)	-1.25	0.00
SROM External Rotation (Left Active)	-2.25	2.50

12. Secondary Outcome

Title	Symptoms - Vanderbilt Head and Neck Symptom Survey
Description	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

Outcome Measure Data

Analysis Population Description

Data was not available and/or applicable to all participants in certain categories.

Arm/Group Title	Wait-list Control Group	Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).	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.
Measure Participants	24	19
Mouth Pain	0.00	0.00
General Pain	0.67	0.00
Swallowing Solids	-0.06	-0.25
Swallowing Liquids	0.00	0.00
Nutrition	0.00	0.00
Mucous	-0.12	-0.50
Dry Mouth	0.20	0.00
Taste/Smell	-0.25	-0.17
Voice	-0.67	-.033
Teeth	0.25	0.00

13. Secondary Outcome

Title	Quality of Life - Linear Analog Self-Assessment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wait-list Control Group	Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).	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.
Measure Participants	24	19
-4	1 4.2%	0 0%
-2	1 4.2%	0 0%
-1	5 20.8%	3 15.8%
0	10 41.7%	13 68.4%
1	4 16.7%	2 10.5%
2	2 8.3%	1 5.3%
4	1 4.2%	0 0%

14. Secondary Outcome

Title	Symptoms - Lymphedema Symptom Intensity and Distress Survey
Description	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

Outcome Measure Data

Analysis Population Description

Data may be missing or left blank by participant.

Arm/Group Title	Wait-list Control Group	Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).	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.
Measure Participants	24	19
Soft Tissue	0.00	-2.00
Neurological	0.00	0.00
Oral	0.00	0.00
BioBehavioral	0.00	0.00
Resources	0.00	0.00
Sexuality	0.00	0.00
Activity	0.00	0.0
Function	0.00	0.00

Adverse Events

Time Frame	8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
Arm/Group Title	Wait-list Control Group		Interventional Group
Arm/Group Description	Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).		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.
All Cause Mortality
	Wait-list Control Group		Interventional Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/24 (4.2%)		0/19 (0%)
Serious Adverse Events
	Wait-list Control Group		Interventional Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/24 (8.3%)		2/19 (10.5%)
General disorders
Sudden death NOS	1/24 (4.2%)	1	0/19 (0%)	0
Infections and infestations
Cellulitis	0/24 (0%)	0	1/19 (5.3%)	1
Metabolism and nutrition disorders
Hyponatremia	1/24 (4.2%)	1	0/19 (0%)	0
Nervous system disorders
Stroke	0/24 (0%)	0	1/19 (5.3%)	1
Other (Not Including Serious) Adverse Events
	Wait-list Control Group		Interventional Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/24 (83.3%)		14/19 (73.7%)
Cardiac disorders
Chest Pain - Cardiac	1/24 (4.2%)	1	0/19 (0%)	0
Hypertension	1/24 (4.2%)	2	1/19 (5.3%)	1
Ear and labyrinth disorders
Hearing impaired	1/24 (4.2%)	1	0/19 (0%)	0
Endocrine disorders
Hypothyroidism	2/24 (8.3%)	2	1/19 (5.3%)	1
Hyperthyroidism	0/24 (0%)	0	1/19 (5.3%)	1
Eye disorders
Corneal ulcer	1/24 (4.2%)	1	0/19 (0%)	0
Gastrointestinal disorders
Diarrhea	1/24 (4.2%)	1	1/19 (5.3%)	1
Flatulence	1/24 (4.2%)	1	1/19 (5.3%)	1
Gastroesophageal reflux disease	1/24 (4.2%)	1	0/19 (0%)	0
Gastrointestinal fistula	0/24 (0%)	0	1/19 (5.3%)	1
General disorders
Aphonia	1/24 (4.2%)	1	0/19 (0%)	0
General disorders and administration site conditions - other specify	1/24 (4.2%)	1	0/19 (0%)	0
Neck pain	1/24 (4.2%)	1	1/19 (5.3%)	1
Oral pain	1/24 (4.2%)	1	1/19 (5.3%)	1
Pain	3/24 (12.5%)	3	1/19 (5.3%)	1
Immune system disorders
Allergic reaction	1/24 (4.2%)	1	1/19 (5.3%)	1
Infections and infestations
Bladder infection	1/24 (4.2%)	1	0/19 (0%)	0
Eye infection	1/24 (4.2%)	1	0/19 (0%)	0
Middle ear inflammation	1/24 (4.2%)	1	1/19 (5.3%)	1
Pneumonitis	1/24 (4.2%)	1	0/19 (0%)	0
Upper respiratory infection	2/24 (8.3%)	3	0/19 (0%)	0
Infection and infestation - Other, specify	0/24 (0%)	0	1/19 (5.3%)	1
Musculoskeletal and connective tissue disorders
Back pain	0/24 (0%)	0	1/19 (5.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	1/24 (4.2%)	1	0/19 (0%)	0
Nervous system disorders
Dizziness	1/24 (4.2%)	1	0/19 (0%)	0
Headache	1/24 (4.2%)	1	2/19 (10.5%)	4
Myelitis	1/24 (4.2%)	1	1/19 (5.3%)	1
Peripheral sensory neuropathy	2/24 (8.3%)	2	0/19 (0%)	0
Spasiticity	1/24 (4.2%)	1	0/19 (0%)	0
Presyncope	0/24 (0%)	0	1/19 (5.3%)	1
Syncope	0/24 (0%)	0	1/19 (5.3%)	1
Psychiatric disorders
Depression	2/24 (8.3%)	2	0/19 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	1/24 (4.2%)	1	0/19 (0%)	0
Hoarseness	1/24 (4.2%)	1	1/19 (5.3%)	1
Nasal congestion	3/24 (12.5%)	3	1/19 (5.3%)	1
Postnasal drip	3/24 (12.5%)	3	3/19 (15.8%)	3
Respiratory, thoracic and mediastinal disorders - Other, specify	1/24 (4.2%)	1	0/19 (0%)	0
Wheezing	1/24 (4.2%)	1	0/19 (0%)	0
Skin and subcutaneous tissue disorders
Pruritus	2/24 (8.3%)	2	0/19 (0%)	0
Skin and subcutaneous tissue disorders - Other, specify	1/24 (4.2%)	1	0/19 (0%)	0
Skin infection	2/24 (8.3%)	2	0/19 (0%)	0
Surgical and medical procedures
Surgical and medical procedures - Other, specify	1/24 (4.2%)	1	3/19 (15.8%)	3

Limitations/Caveats

This trial was designed as a pilot study and thus the sample size is small.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.