Head and Neck NeoplasmsPhase 1/2NCT02946021
Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema
A Phase 1/2 study testing Head and neck garments for pneumatic compression device and NIRFLI with ICG in people with Head and Neck Neoplasms and Head and Neck Lymphedema, run by Tactile Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Head and Neck Lymphedema, Head and Neck Cancer
- What is being tested?
- Head and neck garments for pneumatic compression device and NIRFLI with ICG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Feb 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Assessment of Lymphatic Structure and Function Pre- and Post- Treatment and During Recovery in Head and Neck Cancer Patients Using NIR Fluorescence Lymphatic Imaging
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.
Read the 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.
- Being tested
- Head and neck garments for pneumatic compression device, NIRFLI with ICG
- Keywords
- Lymphedema, Cancer, Head Cancer, Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms, Lymphedema, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head and neck garments for pneumatic compression deviceDevice
Also called Flexitouch system
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 ICGDrug
Also called Near Infrared Fluorescence Imaging with Indocyanine Green
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.
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic Compression-1 session per day | Experimental | Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green). Receives: Device: Head and neck garments for pneumatic compression device; Drug: NIRFLI with ICG |
| Pneumatic Compression-2 sessions per day | Experimental | Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green). Receives: Device: Head and neck garments for pneumatic compression device; Drug: NIRFLI with ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single Treatment, 2 Weeks of Treatment
Secondary outcomes (3)
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.
Measured: Single Treatment, 2 Weeks of Treatment
Symptom Alleviation Measured by Survey Response.
Alleviates lymphedema symptoms as measured by survey response.
Measured: Single Treatment, 2 Weeks of Treatment
Ease of Use Measured by Survey Response.
Flexitouch is easy to use as measured by survey responses.
Measured: Single Treatment, 2 Weeks of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tactile Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Rasmussen, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946021
- Sponsor's protocol ID
- HSC-MS-16-0465
- Status last verified
- Mar 2019
- First submitted
- 20 Oct 2016
- Last updated
- 9 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lymphatic Structure and Function Pre- and Post- Treatment and During Recovery in Head and Neck Cancer Patients Using NIR Fluorescence Lymphatic Imaging
- ClinicalTrials.gov ID
- NCT02946021
- Acronym / sponsor ID
- HSC-MS-16-0465
- Keywords
- Lymphedema, Cancer, Head Cancer, Neck Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Tactile MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Posted 20 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumatic Compression-1 session per day | Experimental | Device: Head and neck garments for pneumatic compression device, Drug: NIRFLI with ICGHead and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green). |
| Pneumatic Compression-2 sessions per day | Experimental | Device: Head and neck garments for pneumatic compression device, Drug: NIRFLI with ICGHead and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head and neck garments for pneumatic compression deviceAlso: Flexitouch systemPneumatic 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 | Device | Pneumatic Compression-1 session per day, Pneumatic Compression-2 sessions per day |
| NIRFLI with ICGAlso: Near Infrared Fluorescence Imaging with Indocyanine GreenNear-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. | Drug | Pneumatic Compression-1 session per day, Pneumatic Compression-2 sessions per day |
Primary outcome
Lymph Movement Measured by ICG Lymphography.
Time frame: 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.
3 secondary outcomes
Dermal Backflow Measured by ICG Lymphography.
Time frame: Single Treatment, 2 Weeks of Treatment
Symptom Alleviation Measured by Survey Response.
Time frame: Single Treatment, 2 Weeks of Treatment
Ease of Use Measured by Survey Response.
Time frame: Single Treatment, 2 Weeks of Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Rasmussen, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Head and neck garments for pneumatic compression device and NIRFLI with ICG in people with Head and Neck Neoplasms and Head and Neck Lymphedema, run by Tactile Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymph Movement Measured by ICG Lymphography. (time frame: Single Treatment, 2 Weeks of Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.