Lymphedema of FacePhase 1NCT05937269
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship
A Phase 1 study testing Near-infrared fluorescence lymphatic imaging and advanced pneumatic compression therapy in people with Lymphedema of Face and Head and Neck Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if treating the lymphatics in head and neck cancer survivors before clinical diagnosis of lymphedema will prevent its development or progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema of Face, Head and Neck Cancer
- What is being tested?
- Near-infrared fluorescence lymphatic imaging and advanced pneumatic compression therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 have previously been diagnosed with head and neck cancer and undergone surgery and radiation as part of their standard-of-care treatment plan
- Participants must be ≥ 4 weeks but less than 3 months post-radiation therapy at enrollment
- 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
- Male participants must agree to shave facial hair on imaging days
- Participants must be willing and able to independently use the pneumatic compression device at home daily for up to 12 months as directed by study personnel.
Who cannot join
- Persons who are pregnant or breast-feeding
- Females of child-bearing potential, who do not agree to use an approved contraceptive for one month after each imaging session
- Persons who do not meet inclusion criteria
- Iodine allergy
- Persons with a chest circumference of 150 cm or more
- Uncontrolled hyperthyroidism or parathyroidism (for which an endocrinologist recommends against neck compression)
Show all 18Show fewer
- 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 or internal jugular venous thrombosis (within 3 months)
- Increased 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 to 8-weeks post-operative
- Facial or head and neck dermal metastasis
- Acute facial infection (e.g., facial, or parotid gland abscess)
- Heart failure (acute pulmonary edema, decompensated acute heart failure)
- Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
- Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene)
- Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin, or untreated inflammatory skin disease)
- Any condition where increased venous and lymphatic return is undesirable
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck
The goal of this clinical trial is to learn if treating the lymphatics in head and neck cancer survivors before clinical diagnosis of lymphedema will prevent its development or progression. The main questions it aims to answer are:
- Does early lymphatic treatment, before onset of clinical symptoms, prevent the development of head and neck lymphedema?
- Does dermal lymphatic backflow provide an early indication of lymphedema and its response to treatment?
Over the course of one year, participants will undergo several sessions near-infrared fluorescence lymphatic imaging to assess whether they have abnormal dermal lymphatic backflow following head and neck cancer treatment. Subjects will be divided into two groups, a treated and a control group. The treated group will be asked to complete daily sessions of pneumatic compression therapy at home, while the control group will receive standard-of-card treatment after clinical diagnosis of lymphedema. Researchers will compare the incidence of lymphedema between the two groups to see if treatment before diagnosis prevents the development and progression of head and neck lymphedema.
- Conditions
- Lymphedema of Face, Head and Neck Cancer
- Being tested
- Near-infrared fluorescence lymphatic imaging, advanced pneumatic compression therapy
- Keywords
- indocyanine green imaging, head and neck cancer-acquired lymphedema, near-infrared fluorescence lymphatic imaging, advanced pneumatic compression therapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared fluorescence lymphatic imagingCombination product
Also called indocyanine green imaging
All subjects will undergo lymphatic imaging at enrollment, 3, 6, and 12 months to assess the extent of dermal lymphatic backflow. Small amounts (0.1 mL) of a solution of indocyanine green (ICG) will be intradermally injected near the ear and along the jaw. Images of the lymphatics will be acquired by shining a dim light on the face and neck and acquiring the resulting fluorescent signal emanating from ICG-laden lymph. Images will be processed to calculate the area of the head and neck that show abnormal dermal lymphatic backflow.
advanced pneumatic compression therapyDevice
The advanced pneumatic compression device (APCD) mimics manual lymphatic drainage, a light massage that stimulates lymphatic uptake and function and frequently prescribed for lymphedema therapy.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Pneumatic Compression | Experimental | Subjects who present with dermal lymphatic backflow will be asked to complete a session of advanced pneumatic compression therapy each day at home. Receives: Combination Product: Near-infrared fluorescence lymphatic imaging; Device: advanced pneumatic compression therapy |
| Standard-of-Care | Active comparator | Subjects who present with dermal lymphatic backflow will continue under standard-of-care surveillance of lymphedema and will only receive treatment if they are diagnosed with head and neck cancer-acquired lymphedema. Receives: Combination Product: Near-infrared fluorescence lymphatic imaging |
| No Dermal Backflow | Other | Subjects who do not present with dermal lymphatic backflow at enrollment will be monitored at subsequent visits and if/when dermal lymphatic backflow is observed will be randomized into either Advanced Pneumatic Compression or Standard-of-Care arm. Receives: Combination Product: Near-infrared fluorescence lymphatic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence/Severity of lymphedema
The incidence of lymphedema between the control and treated groups will be compared.
Measured: Enrollment
Incidence/Severity of lymphedema
The incidence of lymphedema between the control and treated groups will be compared.
Measured: 3 months
Incidence/Severity of lymphedema
The incidence of lymphedema between the control and treated groups will be compared.
Measured: 6 months
Incidence/Severity of lymphedema
The incidence of lymphedema between the control and treated groups will be compared.
Measured: 12 months
Secondary outcomes (3)
Change in area of dermal lymphatic backflow
The change (from enrollment) in the area of the head and neck that is covered by abnormal dermal lymphatic backflow as assessed using near-infrared fluorescence lymphatic imaging.
Measured: 3 months
Change in area of dermal lymphatic backflow
The change (from 3 months) in the area of the head and neck that is covered by abnormal dermal lymphatic backflow as assessed using near-infrared fluorescence lymphatic imaging.
Measured: 6 months
Change in area of dermal lymphatic backflow
The change (from 6 months) in the area of the head and neck that is covered by abnormal dermal lymphatic backflow as assessed using near-infrared fluorescence lymphatic imaging.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start12 Oct 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema of FaceStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Rasmussen, The University of Texas Health Science Center, Houston
- Investigators
- John Rasmussen, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937269
- Sponsor's protocol ID
- HSC-MS-23-0268
- Status last verified
- Aug 2026
- First submitted
- 22 Jun 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Results will be published in a scientific journal along with description of protocol. The complete data set includes large (GBs) sequences of images as well as protected health information (faces). Partial, redacted data sets may be sharable upon request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck
- ClinicalTrials.gov ID
- NCT05937269
- Acronym / sponsor ID
- HSC-MS-23-0268
- Conditions
- Lymphedema of Face, Head and Neck Cancer
- Keywords
- indocyanine green imaging, head and neck cancer-acquired lymphedema, near-infrared fluorescence lymphatic imaging, advanced pneumatic compression therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if treating the lymphatics in head and neck cancer survivors before clinical diagnosis of lymphedema will prevent its development or progression. The main questions it aims to answer are:
- Does early lymphatic treatment, before onset of clinical symptoms, prevent the development of head and neck lymphedema?
- Does dermal lymphatic backflow provide an early indication of lymphedema and its response to treatment?
Over the course of one year, participants will undergo several sessions near-infrared fluorescence lymphatic imaging to assess whether they have abnormal dermal lymphatic backflow following head and neck cancer treatment. Subjects will be divided into two groups, a treated and a control group. The treated group will be asked to complete daily sessions of pneumatic compression therapy at home, while the control group will receive standard-of-card treatment after clinical diagnosis of lymphedema. Researchers will compare the incidence of lymphedema between the two groups to see if treatment before diagnosis prevents the development and progression of head and neck lymphedema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Advanced Pneumatic Compression | Experimental | Combination Product: Near-infrared fluorescence lymphatic imaging, Device: advanced pneumatic compression therapySubjects who present with dermal lymphatic backflow will be asked to complete a session of advanced pneumatic compression therapy each day at home. |
| Standard-of-Care | Active comparator | Combination Product: Near-infrared fluorescence lymphatic imagingSubjects who present with dermal lymphatic backflow will continue under standard-of-care surveillance of lymphedema and will only receive treatment if they are diagnosed with head and neck cancer-acquired lymphedema. |
| No Dermal Backflow | Other | Combination Product: Near-infrared fluorescence lymphatic imagingSubjects who do not present with dermal lymphatic backflow at enrollment will be monitored at subsequent visits and if/when dermal lymphatic backflow is observed will be randomized into either Advanced Pneumatic Compression or Standard-of-Care arm. |
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 have previously been diagnosed with head and neck cancer and undergone surgery and radiation as part of their standard-of-care treatment plan
- Participants must be ≥ 4 weeks but less than 3 months post-radiation therapy at enrollment
- 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
Key exclusion criteria (18 listed)
- Persons who are pregnant or breast-feeding
- Females of child-bearing potential, who do not agree to use an approved contraceptive for one month after each imaging session
- Persons who do not meet inclusion criteria
- Iodine allergy
- Persons with a chest circumference of 150 cm or more
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 |
|---|---|---|
| Near-infrared fluorescence lymphatic imagingAlso: indocyanine green imagingAll subjects will undergo lymphatic imaging at enrollment, 3, 6, and 12 months to assess the extent of dermal lymphatic backflow. Small amounts (0.1 mL) of a solution of indocyanine green (ICG) will be intradermally injected near the ear and along the jaw. Images of the lymphatics will be acquired by shining a dim light on the face and neck and acquiring the resulting fluorescent signal emanating from ICG-laden lymph. Images will be processed to calculate the area of the head and neck that show abnormal dermal lymphatic backflow. | Combination product | Advanced Pneumatic Compression, No Dermal Backflow, Standard-of-Care |
| advanced pneumatic compression therapyThe advanced pneumatic compression device (APCD) mimics manual lymphatic drainage, a light massage that stimulates lymphatic uptake and function and frequently prescribed for lymphedema therapy. | Device | Advanced Pneumatic Compression |
Primary outcome
Incidence/Severity of lymphedema
Time frame: Enrollment
The incidence of lymphedema between the control and treated groups will be compared.
Incidence/Severity of lymphedema
Time frame: 3 months
The incidence of lymphedema between the control and treated groups will be compared.
Incidence/Severity of lymphedema
Time frame: 6 months
The incidence of lymphedema between the control and treated groups will be compared.
Incidence/Severity of lymphedema
Time frame: 12 months
The incidence of lymphedema between the control and treated groups will be compared.
3 secondary outcomes
Change in area of dermal lymphatic backflow
Time frame: 3 months
Change in area of dermal lymphatic backflow
Time frame: 6 months
Change in area of dermal lymphatic backflow
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No. Results will be published in a scientific journal along with description of protocol. The complete data set includes large (GBs) sequences of images as well as protected health information (faces). Partial, redacted data sets may be sharable upon request.
Related trials for Lymphedema of Face
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Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani
Lymphedema, Lymphedema of Face
Recruiting
Manual Lymph Drainage for External Lymphedema
Lymphedema of Face, Neoplasms
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 study testing Near-infrared fluorescence lymphatic imaging and advanced pneumatic compression therapy in people with Lymphedema of Face and Head and Neck Cancer, run by The University of Texas Health Science Center, Houston 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 18 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence/Severity of lymphedema (time frame: Enrollment). The study lists 4 primary outcomes in all. 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 27 Aug 2026.