Neoplasms

All Conditions

Blood and Lymph Conditions

Head and Neck Neoplasms

Lymphedema

Lymphatic Diseases

Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).

Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).

Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds; and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema

Head and neck garments for pneumatic compression device

Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.

NIRFLI with ICG

John Rasmussen, PhD

Assessment of lymphatic structure and function pre- and post- treatment and during recovery in head and neck cancer related lymphedema patients using NIR fluorescence lymphatic imaging: Response to ICD therapy in HNC Patients.

A non-randomized, non-blinded, single site pilot study designed to assess whether near-infrared fluorescence imaging can report on the efficacy of a pneumatic compression device to move lymph in head and neck cancer survivors with resulting head and neck lymphedema.

Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema

Assessment of Lymphatic Structure and Function Pre- and Post- Treatment and During Recovery in Head and Neck Cancer Patients Using NIR Fluorescence Lymphatic Imaging

Demonstrate the ability of the Flexitouch system to move lymph/enhance lymphatic uptake (indicated by increased functionality of vessels and/or changes in area of dermal backflow) as measured by Indocyanine Green (ICG) lymphography.

Resolves dermal backflow as measured by ICG lymphography. A positive change in area indicates an increase in observable abnormal lymphatics, while a negative change indicates a decrease in observable abnormal lymphatics. A positive increase after a single treatment is expected as the manual stimulation of the lymphatics promotes the movement of ICG through the lymphatic space; however, a decrease over time provides an indication of improved lymphatic recovery.

Alleviates lymphedema symptoms as measured by survey response.

Flexitouch is easy to use as measured by survey responses.

Tactile Medical

Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).

Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema

NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.

Pneumatic Compression-1 Session Per Day

Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).

Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema

NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.

Pneumatic Compression-2 Sessions Per Day

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

One subject reported wearing the head garment upside down during the two week treatment period, therefore the subject was excluded from the analysis population and replaced with another subject to meet the requirement for 10 analyzable data sets.

Jill Christensen

Lymph Movement after Single Treatment

Lymph Movement after 2 Weeks of Treatment

The analysis population included all enrolled subjects who completed the study and properly used the device. One subject reported wearing the head garment upside down during the two week treatment period, therefore the subject was excluded from the analysis population for a cohort of 10 analyzable data sets.

Lymph Movement Measured by ICG Lymphography.

Dermal Backflow after Single Treatment)

Dermal Backflow after 2 Weeks of Treatments

Dermal Backflow Measured by ICG Lymphography.

After Single Treatment

After 2 Weeks of Treatment

Symptom Alleviation Measured by Survey Response.

Ability to Don after Single Treatment

Ability to Don after 2 Weeks of Treatment

Ability to Doff after Single Treatment

Ability to Doff after 2 Weeks of Treatment

Ease of Use Measured by Survey Response.

Overall Study

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Mouth Neoplasms

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Mouth Diseases

Oral Cancer

Lip and Oral Cavity Cancer

If CDT is declined, participants will have follow-up visits at 1, 3, and 6 months after study interview.

Follow -Up Visits

Monday through Friday visits to the clinic for 2 weeks of intensive outpatient therapy. The CDT will be done by the lymphedema therapist. Each session will last about 1 hour.

During the last 2 treatment visits (Visits 9 and 10), the participant will be taught how to do the CDT steps at home. Then, the CDT steps will be performed at home, every day for the next 3 months.

Full CDT

The participant will come to the clinic for 1-2 training sessions taught by the lymphedema therapist. Each training session will last about 1 hour, and the participant will be taught how to do the CDT steps at home. Then, the CDT steps will be performed at home, every day for the next 3 months.

Modified CDT Program

Jan S Lewin, PhD

Objectives:

Specific Aim 1: Estimate the prevalence of head and neck lymphedema in patients who have been treated with surgery and/or radiation therapy (± chemotherapy) for oral cavity and oropharyngeal cancer.

Compare functional outcomes in patients with and without lymphedema using cross-sectional survey methods.

Specific Aim 2: Evaluate the effect of Complete Decongestive Therapy (CDT) provided in an outpatient setting or a home-based program in reducing lymphedema in patients previously treated with surgery and/or radiation therapy (± chemotherapy) for oral cavity and oropharyngeal cancer at 1, 3 and 6 months follow-up. Patient characteristics, treatment variables, and the health care environment will be analyzed as possible explanatory variables that influence the effect of lymphedema treatment.

Specific Aim 3: Evaluate the effect of lymphedema treatment on symptom burden, self-image, and functional performance status in patients previously treated with surgery and/or radiation therapy (± chemotherapy) for oral cavity and oropharyngeal cancer.

Screening for Part 1 of the Study:

The research staff will review your medical record to find out if you are possibly eligible to join Part 1 of this study. You will be eligible if you have had radiation and/or surgery (with or without chemotherapy) for mouth or throat cancer and it has been at least 1 month since your last treatment.

Part 1 of the Study:

If you choose to participate in Part 1 of this study, you will complete questionnaires. The questionnaires ask about your ability to swallow, eat, and speak, and about your quality of life, your satisfaction with your body, and any head and neck cancer symptoms. In total, the questionnaires should take less than 30 minutes to complete. You will also be asked about any symptoms of lymphedema. Your answers will be compared to the answers of patients who do and do not have lymphedema.

If you do not join Part 2 of this study, your participation in this study will be over after you complete the questionnaires.

Screening for Part 2 of the Study:

If you have head and neck lymphedema, you may also be eligible for Part 2 of the study. You will have "screening tests" to help the doctor decide if you are eligible for Part 2 of the study:

* The answers you provide to a questionnaire during Part 1 of the study will help the doctor find out if you may have lymphedema.
* Blood (about 1/2 teaspoon) will be drawn to check your thyroid function.
* Your doctor will also check your face and neck for signs of lymphedema during your regular clinic visit.

The research staff will discuss the Part 2 screening test results with you, if applicable. Signing this consent form does not mean that you will be able to participate in Part 2 of this study. If the screening tests show that you are not eligible for Part 2, you will only be enrolled in Part 1.

Part 2 of the Study:

If you are found to be eligible to take part in Part 2 of this study, you will first meet with a certified lymphedema therapist in the Head and Neck Center. During this visit, the therapist will perform a lymphedema exam. This involves checking your neck, face, and mouth for swelling, and looking at your skin to check for any open wounds or infection. The therapist will also interview you about how well you are able to swallow, eat, speak, and perform other normal activities of daily living (performance status). This visit should last about 1 hour.

All Part 2 participants will be offered CDT. It will be your choice if you would like to receive a "full" CDT program or a "modified" CDT program. You may also choose to decline both of these CDT options and stay on study for follow-up.

CDT has 4 steps that are designed to help the lymph fluids flow:

* Soft tissue of the face and neck is gently massaged, from inside or outside the mouth. This lasts for about 30-45 minutes.
* Bandages are placed on the face and neck in order to apply gentle pressure to the affected areas. The bandages stay in place for about 2-3 hours, before and/or after the massage.
* The face and neck muscles are exercised a certain way for about 15 minutes or less, while the bandages are in place.
* The face and neck is washed a certain way for about 5 minutes or less.

All 4 steps are done in both the full and modified CDT programs. The difference between the full and modified programs is that the full program includes 10 CDT sessions at the clinic, in addition to a self-managed CDT program at home. Otherwise, the 4 steps of CDT are the same in both the clinic sessions and home sessions.

Full CDT Program:

If you choose to receive the full CDT program, you will come to the clinic and receive CDT as described above, Monday through Friday for 2 weeks of intensive outpatient therapy. The CDT will be done by the lymphedema therapist. Each session will last about 1 hour.

During your last 2 treatment visits (Visits 9 and 10), you will be taught how to do the CDT steps at home. You will then perform the CDT steps at home, every day for the next 3 months.

Modified CDT Program:

If you choose to receive the modified CDT program, you will come to the clinic for 1-2 training sessions taught by the lymphedema therapist. Each training session will last about 1 hour, and you will be taught how to do the CDT steps at home. You will then perform the CDT steps at home, every day for the next 3 months.

Option for No CDT:

If you decline both study treatment options, you will not receive CDT. You will stay on study to receive follow-up as described below.

Follow-Up in Part 2 of the Study:

All Part 2 study participants will have 3 follow-up visits. If you received the full or modified CDT program, the visits will be at 1, 3, and 6 months after your first lymphedema training session. If you declined the CDT, the visits will be at 1, 3, and 6 months after your study interview.

At these visits, you will complete the same questionnaires as you did for screening in Part 1 of the study. You will also have a lymphedema exam and interview by the lymphedema therapist, like you did at the beginning of Part 2 of the study.

If you received the full or modified CDT program, a study staff member will also call you at 2, 6, and 9 weeks after your first lymphedema training session, to ask how the home CDT program is going.

Length of Part 2:

If you are in Part 2, your participation in this study will be over after your 6-month follow-up visit.

This is an investigational study. CDT is commonly used to treat all types of lymphedema, including head and neck lymphedema. This study (Part 2) is designed to collect more data on whether CDT can help to control head and neck lymphedema and its symptoms. Part 1 is also designed to collect data related to head and neck lymphedema.

Up to 500 patients will take part in this study. All will be enrolled at M. D. Anderson.

Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema

Lymphedema in Patients With Oral Cavity and Oropharyngeal Cancer: Prevalence, Functional Effects, and Treatment Outcomes

M.D. Anderson Cancer Center

Symptoms and General Pathology

Neoplasm Metastasis

Selected measurements in healthy persons of skin tissue dielectric constant as reference values for subsequent use to evaluate patients with head and neck lymphedema.

Skin tissue dielectric constant (TDC) measurements will non-invasively be made bilaterally at two neck sites, bilaterally on two forearm sites and one site at the chin sub-mental area.

Measurements are made with subjects fully clothed and seated. Measurements are made in triplicate and averaged at each site. Full measurements take about 5-7 minutest to complete. Data will be analyzed to determine the neck-to-arm ratios and chin-to-arm ratios to establish normal ranges of these parameters for subsequent use as comparisons to evaluate and track changes in patients with head and neck lymphedema.

Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema

Bilateral values and Variability in TDC values

Nova Southeastern University

Professor

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

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

Age, Continuous

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema	NCT02946021	Head and Neck N... Head and Neck L... Head and Neck C...	Head and neck g... NIRFLI with ICG	18 Years -	Tactile Medical
Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema	NCT00951470	Lymphedema Oropharyngeal C... Head and Neck C... Oral Cancer	Follow -Up Visi... Full CDT Modified CDT Pr...	18 Years -	M.D. Anderson Cancer Center
Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema	NCT04457375	Lymphedema, Sec...	TDC	18 Years -	Nova Southeastern University
Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema	NCT00951470	Lymphedema Oropharyngeal C... Head and Neck C... Oral Cancer	Follow -Up Visi... Full CDT Modified CDT Pr...	18 Years -	M.D. Anderson Cancer Center
Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema	NCT00951470	Lymphedema Oropharyngeal C... Head and Neck C... Oral Cancer	Follow -Up Visi... Full CDT Modified CDT Pr...	18 Years -	M.D. Anderson Cancer Center
A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment	NCT03332160	Head and Neck N... Head and Neck C... Head and Neck L...	Flexitouch head... Standard home l...	18 Years -	Tactile Medical

Spots Global Cancer Trial Database for head and neck lymphedema