Neoplasms

All Conditions

Blood and Lymph Conditions

Head and Neck Neoplasms

Lymphedema

Lymphatic Diseases

Daily treatment with Flexitouch® pneumatic compression device for treatment of head and neck lymphedema and standard home lymphedema care

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.

Flexitouch head and neck lymphedema treatment system

May include daily self manual lymphatic drainage, exercise, skin care, compression garments (as appropriate).

Standard home lymphedema care

Sheila Ridner, PhD, RN

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.

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.

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

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.

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.

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.

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%.

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.

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%.

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.

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.

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.

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.

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.

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 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.

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.

Vanderbilt University

Tactile Medical

Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).

Wait-list Control 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.

Interventional Group

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

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Education

Marital Status

Residence

Divided weight (in pounds) by height (in inches) squared and multiplied by 703

Body Mass Index (BMI) at Enrollment

Smoking history/current

Alcohol history/current

Tracheotomy at Enrollment

Percutaneous Endoscopic Gastrostomy (PEG) at Enrollment

Months since Lymphedema Diagnosis

Months since Initial Lymphedema Treatment

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

Heather Smith

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Week 8

This analysis only applies to the Interventional Group.

Fidelity/Adherence Via Subject Diary

Cardiac disorders

Ear and labyrinth disorders

Endocrine disorders

Eye disorders

Gastrointestinal disorders

General disorders

Immune system disorders

Infections and infestations

Musculoskeletal and connective tissue disorders

Neoplasms benign, malignant and unspecified

Nervous system disorders

Psychiatric disorders

Skin and subcutaneous tissue disorders

Surgical and medical procedures

Respiratory, thoracic and mediastinal disorders

Vascular disorders

Adverse Events

Baseline (Good, Very Good, or Excellent)

8 Weeks (Good, Very Good, or Excellent)

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.

Treatment Satisfaction

Reduction in Swelling/Inflammation - Endoscopy

Not all participants' blood samples were analyzable.

Reduction in Swelling/Inflammation - Cytokine Levels

Front View Change

Right View Change

Left View Change

Reduction in Swelling/Inflammation - Digital Photography

Reduction in Swelling/Inflammation - Grading of External Lymphedema

Function - Jaw Range of Motion

Function - Neck Disability Index

Function - Voice Handicap Index

CROM Forward Flexion

CROM Extension

CROM Left Lateral Rotation

CROM Right Lateral Rotation

SROM Forward Flexion (Right Active)

SROM Forward Flexion (Left Active)

SROM Abduction (Right Active)

SROM Abduction (Left Active)

SROM External Rotation (Right Active)

SROM External Rotation (Left Active)

Function - Cervical and Shoulder Range of Motion

Mouth Pain

General Pain

Swallowing Solids

Swallowing Liquids

Nutrition

Mucous

Dry Mouth

Taste/Smell

Voice

Teeth

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

Symptoms - Vanderbilt Head and Neck Symptom Survey

Quality of Life - Linear Analog Self-Assessment

Soft Tissue

Neurological

Oral

BioBehavioral

Resources

Sexuality

Activity

Function

Data may be missing or left blank by participant.

Symptoms - Lymphedema Symptom Intensity and Distress Survey

Standard home lymphedema care: May include daily self manual lymphatic drainage (MLD), exercise, skincare, compression garments (as appropriate)

Spots Global Cancer Trial Database for flexitouch head and neck lymphedema treatment system