Head and Neck Cancer, Head and Neck Lymphedema, Head and Neck Neoplasms
Conditions
Keywords
Lymphedema, Cancer, Head Cancer, Neck Cancer
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHead 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
DRUGNIRFLI 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.
Sponsors
Tactile Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be 18 years of age or older * Participants must be diagnosed with Lymphedema of the Head and/or Neck * Participants must be diagnosed with squamous cell carcinoma of the oral cavity, oropharynx or larynx and underwent surgery and radiation as part of their standard-of-care treatment plan. * Participants must be ≥ 4 weeks post-radiation therapy * Female participants of childbearing potential must have a negative urine pregnancy test ≤ 36 hours prior to study drug administration * Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month after each imaging session * Participants must be willing to use the Flexitouch® System at home daily for two (2) weeks
Exclusion criteria
* Women who are pregnant or breast-feeding * Persons who are allergic to iodine * A female of child-bearing potential, who does not agree to use an approved contraceptive for one month after study participation * Persons who do not meet inclusion criteria * Persons with pulmonary edema, thrombophlebitis, congestive heart failure, deep vein thrombosis, episodes of pulmonary embolism, infections and inflammation, or acute cancer * Persons with uncontrolled hyperthyroidism or parathyroidism (for with an 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 * Known intracranial pressure or other contraindication 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 where increased venous and lymphatic return is undesirable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymph Movement Measured by ICG Lymphography. | Single Treatment, 2 Weeks of Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermal Backflow Measured by ICG Lymphography. | Single Treatment, 2 Weeks of Treatment | 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. |
| Symptom Alleviation Measured by Survey Response. | Single Treatment, 2 Weeks of Treatment | Alleviates lymphedema symptoms as measured by survey response. |
| Ease of Use Measured by Survey Response. | Single Treatment, 2 Weeks of Treatment | Flexitouch is easy to use as measured by survey responses. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pneumatic Compression-1 Session Per Day 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. | 6 |
| Pneumatic Compression-2 Sessions 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. | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Total | Pneumatic Compression-2 Sessions Per Day | Pneumatic Compression-1 Session Per Day |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 5 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 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 | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 4 Participants | 6 Participants |
| Region of Enrollment United States | 11 participants | 5 participants | 6 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 10 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 3 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
Primary
Lymph Movement Measured by ICG Lymphography.
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.
Time frame: Single Treatment, 2 Weeks of Treatment
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pneumatic Compression-1 Session Per Day | Lymph Movement Measured by ICG Lymphography. | Lymph Movement after Single Treatment | Enhanced Lymphatic Uptake | 5 Participants |
| Pneumatic Compression-1 Session Per Day | Lymph Movement Measured by ICG Lymphography. | Lymph Movement after Single Treatment | No Enhanced Lymphatic Uptake | 0 Participants |
| Pneumatic Compression-1 Session Per Day | Lymph Movement Measured by ICG Lymphography. | Lymph Movement after 2 Weeks of Treatment | Enhanced Lymphatic Uptake | 5 Participants |
| Pneumatic Compression-1 Session Per Day | Lymph Movement Measured by ICG Lymphography. | Lymph Movement after 2 Weeks of Treatment | No Enhanced Lymphatic Uptake | 0 Participants |
| Pneumatic Compression-2 Sessions Per Day | Lymph Movement Measured by ICG Lymphography. | Lymph Movement after 2 Weeks of Treatment | No Enhanced Lymphatic Uptake | 1 Participants |
| Pneumatic Compression-2 Sessions Per Day | Lymph Movement Measured by ICG Lymphography. | Lymph Movement after Single Treatment | Enhanced Lymphatic Uptake | 5 Participants |
| Pneumatic Compression-2 Sessions Per Day | Lymph Movement Measured by ICG Lymphography. | Lymph Movement after 2 Weeks of Treatment | Enhanced Lymphatic Uptake | 4 Participants |
| Pneumatic Compression-2 Sessions Per Day | Lymph Movement Measured by ICG Lymphography. | Lymph Movement after Single Treatment | No Enhanced Lymphatic Uptake | 0 Participants |
Secondary
Dermal Backflow Measured by 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.
Time frame: Single Treatment, 2 Weeks of Treatment
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pneumatic Compression-1 Session Per Day | Dermal Backflow Measured by ICG Lymphography. | Dermal Backflow after Single Treatment) | Positive Change in Area | 4 Participants |
| Pneumatic Compression-1 Session Per Day | Dermal Backflow Measured by ICG Lymphography. | Dermal Backflow after Single Treatment) | Negative Change in Area | 0 Participants |
| Pneumatic Compression-1 Session Per Day | Dermal Backflow Measured by ICG Lymphography. | Dermal Backflow after Single Treatment) | No Dermal Backflow/No Change | 1 Participants |
| Pneumatic Compression-1 Session Per Day | Dermal Backflow Measured by ICG Lymphography. | Dermal Backflow after 2 Weeks of Treatments | Positive Change in Area | 1 Participants |
| Pneumatic Compression-1 Session Per Day | Dermal Backflow Measured by ICG Lymphography. | Dermal Backflow after 2 Weeks of Treatments | Negative Change in Area | 3 Participants |
| Pneumatic Compression-1 Session Per Day | Dermal Backflow Measured by ICG Lymphography. | Dermal Backflow after 2 Weeks of Treatments | No Dermal Backflow/No Change | 1 Participants |
| Pneumatic Compression-2 Sessions Per Day | Dermal Backflow Measured by ICG Lymphography. | Dermal Backflow after 2 Weeks of Treatments | Negative Change in Area | 3 Participants |
| Pneumatic Compression-2 Sessions Per Day | Dermal Backflow Measured by ICG Lymphography. | Dermal Backflow after Single Treatment) | Positive Change in Area | 4 Participants |
| Pneumatic Compression-2 Sessions Per Day | Dermal Backflow Measured by ICG Lymphography. | Dermal Backflow after 2 Weeks of Treatments | Positive Change in Area | 1 Participants |
| Pneumatic Compression-2 Sessions Per Day | Dermal Backflow Measured by ICG Lymphography. | Dermal Backflow after Single Treatment) | Negative Change in Area | 0 Participants |
| Pneumatic Compression-2 Sessions Per Day | Dermal Backflow Measured by ICG Lymphography. | Dermal Backflow after 2 Weeks of Treatments | No Dermal Backflow/No Change | 1 Participants |
| Pneumatic Compression-2 Sessions Per Day | Dermal Backflow Measured by ICG Lymphography. | Dermal Backflow after Single Treatment) | No Dermal Backflow/No Change | 1 Participants |
Secondary
Ease of Use Measured by Survey Response.
Flexitouch is easy to use as measured by survey responses.
Time frame: Single Treatment, 2 Weeks of Treatment
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pneumatic Compression-1 Session Per Day | Ease of Use Measured by Survey Response. | Ability to Don after Single Treatment | Minimal Assist | 4 Participants |
| Pneumatic Compression-1 Session Per Day | Ease of Use Measured by Survey Response. | Ability to Doff after Single Treatment | Independently | 4 Participants |
| Pneumatic Compression-1 Session Per Day | Ease of Use Measured by Survey Response. | Ability to Don after 2 Weeks of Treatment | Independently | 4 Participants |
| Pneumatic Compression-1 Session Per Day | Ease of Use Measured by Survey Response. | Ability to Doff after Single Treatment | Minimal Assist | 1 Participants |
| Pneumatic Compression-1 Session Per Day | Ease of Use Measured by Survey Response. | Ability to Don after Single Treatment | Independently | 1 Participants |
| Pneumatic Compression-1 Session Per Day | Ease of Use Measured by Survey Response. | Ability to Doff after Single Treatment | Data Missing | 0 Participants |
| Pneumatic Compression-1 Session Per Day | Ease of Use Measured by Survey Response. | Ability to Don after 2 Weeks of Treatment | Minimal Assist | 1 Participants |
| Pneumatic Compression-1 Session Per Day | Ease of Use Measured by Survey Response. | Ability to Doff after 2 Weeks of Treatment | Independently | 4 Participants |
| Pneumatic Compression-1 Session Per Day | Ease of Use Measured by Survey Response. | Ability to Don after Single Treatment | Data Missing | 0 Participants |
| Pneumatic Compression-1 Session Per Day | Ease of Use Measured by Survey Response. | Ability to Doff after 2 Weeks of Treatment | Minimal Assist | 1 Participants |
| Pneumatic Compression-1 Session Per Day | Ease of Use Measured by Survey Response. | Ability to Don after 2 Weeks of Treatment | Data Missing | 0 Participants |
| Pneumatic Compression-1 Session Per Day | Ease of Use Measured by Survey Response. | Ability to Doff after 2 Weeks of Treatment | Data Missing | 0 Participants |
| Pneumatic Compression-2 Sessions Per Day | Ease of Use Measured by Survey Response. | Ability to Don after 2 Weeks of Treatment | Data Missing | 1 Participants |
| Pneumatic Compression-2 Sessions Per Day | Ease of Use Measured by Survey Response. | Ability to Don after Single Treatment | Independently | 1 Participants |
| Pneumatic Compression-2 Sessions Per Day | Ease of Use Measured by Survey Response. | Ability to Don after Single Treatment | Minimal Assist | 4 Participants |
| Pneumatic Compression-2 Sessions Per Day | Ease of Use Measured by Survey Response. | Ability to Don after Single Treatment | Data Missing | 0 Participants |
| Pneumatic Compression-2 Sessions Per Day | Ease of Use Measured by Survey Response. | Ability to Don after 2 Weeks of Treatment | Independently | 4 Participants |
| Pneumatic Compression-2 Sessions Per Day | Ease of Use Measured by Survey Response. | Ability to Don after 2 Weeks of Treatment | Minimal Assist | 0 Participants |
| Pneumatic Compression-2 Sessions Per Day | Ease of Use Measured by Survey Response. | Ability to Doff after 2 Weeks of Treatment | Data Missing | 2 Participants |
| Pneumatic Compression-2 Sessions Per Day | Ease of Use Measured by Survey Response. | Ability to Doff after Single Treatment | Independently | 3 Participants |
| Pneumatic Compression-2 Sessions Per Day | Ease of Use Measured by Survey Response. | Ability to Doff after Single Treatment | Minimal Assist | 1 Participants |
| Pneumatic Compression-2 Sessions Per Day | Ease of Use Measured by Survey Response. | Ability to Doff after Single Treatment | Data Missing | 1 Participants |
| Pneumatic Compression-2 Sessions Per Day | Ease of Use Measured by Survey Response. | Ability to Doff after 2 Weeks of Treatment | Independently | 3 Participants |
| Pneumatic Compression-2 Sessions Per Day | Ease of Use Measured by Survey Response. | Ability to Doff after 2 Weeks of Treatment | Minimal Assist | 0 Participants |
Secondary
Symptom Alleviation Measured by Survey Response.
Alleviates lymphedema symptoms as measured by survey response.
Time frame: Single Treatment, 2 Weeks of Treatment
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pneumatic Compression-1 Session Per Day | Symptom Alleviation Measured by Survey Response. | After Single Treatment | Felt much better | 0 Participants |
| Pneumatic Compression-1 Session Per Day | Symptom Alleviation Measured by Survey Response. | After Single Treatment | Felt somewhat better | 4 Participants |
| Pneumatic Compression-1 Session Per Day | Symptom Alleviation Measured by Survey Response. | After Single Treatment | Felt about the same | 1 Participants |
| Pneumatic Compression-1 Session Per Day | Symptom Alleviation Measured by Survey Response. | After Single Treatment | Data Missing | 0 Participants |
| Pneumatic Compression-1 Session Per Day | Symptom Alleviation Measured by Survey Response. | After 2 Weeks of Treatment | Felt much better | 0 Participants |
| Pneumatic Compression-1 Session Per Day | Symptom Alleviation Measured by Survey Response. | After 2 Weeks of Treatment | Felt somewhat better | 2 Participants |
| Pneumatic Compression-1 Session Per Day | Symptom Alleviation Measured by Survey Response. | After 2 Weeks of Treatment | Felt about the same | 3 Participants |
| Pneumatic Compression-1 Session Per Day | Symptom Alleviation Measured by Survey Response. | After 2 Weeks of Treatment | Data Missing | 0 Participants |
| Pneumatic Compression-2 Sessions Per Day | Symptom Alleviation Measured by Survey Response. | After 2 Weeks of Treatment | Data Missing | 1 Participants |
| Pneumatic Compression-2 Sessions Per Day | Symptom Alleviation Measured by Survey Response. | After Single Treatment | Felt much better | 2 Participants |
| Pneumatic Compression-2 Sessions Per Day | Symptom Alleviation Measured by Survey Response. | After 2 Weeks of Treatment | Felt much better | 0 Participants |
| Pneumatic Compression-2 Sessions Per Day | Symptom Alleviation Measured by Survey Response. | After Single Treatment | Felt somewhat better | 2 Participants |
| Pneumatic Compression-2 Sessions Per Day | Symptom Alleviation Measured by Survey Response. | After 2 Weeks of Treatment | Felt about the same | 0 Participants |
| Pneumatic Compression-2 Sessions Per Day | Symptom Alleviation Measured by Survey Response. | After Single Treatment | Felt about the same | 1 Participants |
| Pneumatic Compression-2 Sessions Per Day | Symptom Alleviation Measured by Survey Response. | After 2 Weeks of Treatment | Felt somewhat better | 4 Participants |
| Pneumatic Compression-2 Sessions Per Day | Symptom Alleviation Measured by Survey Response. | After Single Treatment | Data Missing | 0 Participants |