Head and Neck CancerNCT06837480
Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema
A study testing LTU-904 Portable Laser Therapy Unit (active laser device) in people with Head and Neck Cancer and Lymphedema of the Head and Neck, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
Trial summary
The U.S. Food and Drug Administration approved photobiomodulation therapy (PBMT) as a treatment for breast cancer-related arm lymphedema (BCRL) in 2006. The investigators conducted two pilot clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lymphedema of the Head and Neck
- What is being tested?
- LTU-904 Portable Laser Therapy Unit (active laser device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2026to 30 Nov 2029
- Phase
- Interventional
- 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
- >18 years of age Biopsy proven head and neck cancer No evidence of cancer at the time of study enrollment, between 12- and 60-month post-cancer treatment Chronic lymphedema (defined as lymphedema persisting for a minimum of 6 months) A minimum of 2 sites of external lymphedema At least 1 site with lymphedema of moderate severity as assessed using the HN-LEF Assessment Criteria Failed lymphedema therapy (defined as any of the following: incomplete response to therapy, progression of lymphedema after therapy, inability to perform effective self-care resulting in fluid re-accumulation; and inability to complete treatment due to systems barriers). In addition, patients must be able to understand English in order to complete questionnaires; and to provide informed consent.
Who cannot join
- Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of PBMT:
- Women of childbearing age and potential Acute cellulitis within the soft tissues in the head and neck region Chronic inflammatory diseases Venous thrombosis Carotid artery stenosis Requiring ongoing use of diuretics and corticosteroids Pre-existing skin rash, ulceration, open wound in the treatment area Active lymphedema or physical therapy (including hyperbaric oxygen or trental) Allergic and other systemic skin diseases
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Latimore, MS contact
United States2 sites, 2 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Barbara Murphy, MD
- Recruiting
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Jie Deng, PhD
About this study
Official title: Placebo-Controlled Phase II Randomized Clinical Trial of Photobiomodulation Therapy in Head and Neck Cancer Survivors With Chronic Lymphedema
The U.S. Food and Drug Administration approved photobiomodulation therapy (PBMT) as a treatment for breast cancer-related arm lymphedema (BCRL) in 2006. The investigators conducted two pilot clinical trials. Results demonstrated the feasibility, acceptability, and preliminary efficacy of PBMT for the treatment of chronic lymphedema in head and neck cancer (HNC) survivors. The objective of this study is to further investigate and confirm the positive effects of PBMT on HNC-related chronic lymphedema.
- Being tested
- LTU-904 Portable Laser Therapy Unit (active laser device), LTU-904 Portable Laser Therapy Unit (sham/inactive laser device)
- Keywords
- Head and neck cancer, chronic lymphedema, photobiomodulation
- 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.
LTU-904 Portable Laser Therapy Unit (active laser device)Device
The RianCorp LTU-904 laser therapy unit (active laser device) will be used for photobiomodulation therapy (PBMT).
LTU-904 Portable Laser Therapy Unit (sham/inactive laser device)Device
The RianCorp LTU-904 laser therapy (sham/inactive laser device) unit will be used for sham therapy.
| Study group | Role | What they receive |
|---|---|---|
| ARM A: PBMT12 | Active comparator | After completion of the baseline measures, participants in ARM A will be scheduled for PBMT twice a week for 6 weeks followed by sham therapy once per week for 6 weeks (a total of 18 sessions: 12 PBMT and 6 sham therapy sessions). Receives: Device: LTU-904 Portable Laser Therapy Unit (active laser device); Device: LTU-904 Portable Laser Therapy Unit (sham/inactive laser device) |
| ARM B: PBMT18 | Active comparator | After completion of the baseline measures, participants in ARM B will be scheduled for PBMT twice a week for 6 weeks followed by PBMT once per week for 6 weeks (a total of 18 PBMT sessions). Receives: Device: LTU-904 Portable Laser Therapy Unit (active laser device) |
| ARM C: Placebo | Sham comparator | After completion of the baseline measures, participants in ARM C will receive sham therapy, twice a week for 6 weeks followed by sham therapy once per week for 6 weeks (a total of 18 sham therapy sessions). Receives: Device: LTU-904 Portable Laser Therapy Unit (sham/inactive laser device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Severity of External Lymphedema
Head and Neck Lymphedema and Fibrosis Assessment Criteria.
External lymphedema is measured by HN-LEF Assessment Criteria. The total external lymphedema severity score is calculated by summing the severity score of each site (total 9 sites, severity score ranging from 0-27). For each site, the severity of LEF includes no lymphedema (=0), mild (=1), moderate (=2), and severe (=3).
Change in total severity of external lymphedema from baseline to 12-month post-intervention visits. A larger reduction in this score means more reduction in the severity of external lymphedema.
Measured: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
Secondary outcomes (6)
Total Severity of Internal Lymphedema
Modified Patterson Scale
Endoscopic exams were performed by a trained oncology provider. Internal lymphedema was scored using the Modified Patterson Scale, which documents internal swelling in the oral cavity, pharynx, and larynx. Four grades are used to rate edema level (normal = 0, mild = 1, moderate = 2, and severe = 3) for each anatomical structure. Sites are marked "N/A" when they are unable to be evaluated. The scale has good intra-rater reliability (weighted kappa, 0.84) and moderate inter-rater reliability (weighted kappa, 0.54).
Change in total severity of external lymphedema from baseline to 12-month post-intervention visits. A larger reduction in this score means more reduction in the severity of external lymphedema.
Measured: Pre-intervention, after 18 sessions (end-of-intervention), 12-month post-intervention
Symptom Burden Score
Head and Neck Lymphedema and Fibrosis Symptom Inventory
Symptom burden is assessed by Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF SI). Higher scores (score ranging from 0-5) indicate increased symptom burden.
Change in symptom burden score from baseline to 12-month post-intervention. A larger reduction in this score means decreased symptom burden.
Measured: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
Jaw Range of Motion Degree
Jaw Range of Motion Scale
Jaw Range of Motion Scale is a validated scale with a ruler in millimeters to measure mouth opening.
Change in jaw range of motion degree from baseline to 12-month post-intervention. A larger increase in this degree means better outcome with increased jaw range of motion.
Measured: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
Neck Range of Motion Degree
Cervical Range of Motion Scale
Cervical Range of Motion Device, a valid and reliable tool, will be used to measure the amount of neck movement (degrees) for the following neck movements: forward flexion, extension, right and left lateral flexion, and right and left rotation.
Change in neck range of motion degree from baseline to 12-month post-intervention. A larger change in this degree means better outcome with increased neck range of motion.
Measured: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
Shoulder Range of Motion Degree
Goniometry
Goniometry is a validated and reliable tool for measuring shoulder range of motion.
Change in shoulder range of motion degree from baseline to 12-month post-intervention. A larger change in this degree means better outcome with increased shoulder range of motion.
Measured: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
Quality of Life Score
Quality of Life Scale (Linear Analog Self-Assessment, LASA)
Quality of Life Scale (Linear Analog Self-Assessment, LASA) has been extensively used in cancer (e.g., HNC) patients. The scale has shown good reliability (alpha=.83-.88) and good concurrent/construct validity. It covers four major components of QOL (i.e., physical, emotional, spiritual, and intellectual).
Change in quality of life score from baseline to 12-month post-intervention. A larger increase in this score means better quality of life.
Measured: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start15 Jan 2026
- Primary completion30 Aug 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jie Deng, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837480
- Sponsor's protocol ID
- UPCC 01325
- Other IDs
- Pending
- Status last verified
- Jun 2026
- First submitted
- 15 Feb 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Phase II Randomized Clinical Trial of Photobiomodulation Therapy in Head and Neck Cancer Survivors With Chronic Lymphedema
- ClinicalTrials.gov ID
- NCT06837480
- Acronym / sponsor ID
- UPCC 01325
- Keywords
- Head and neck cancer, chronic lymphedema, photobiomodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 20 Feb 2025 (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 U.S. Food and Drug Administration approved photobiomodulation therapy (PBMT) as a treatment for breast cancer-related arm lymphedema (BCRL) in 2006. The investigators conducted two pilot clinical trials. Results demonstrated the feasibility, acceptability, and preliminary efficacy of PBMT for the treatment of chronic lymphedema in head and neck cancer (HNC) survivors. The objective of this study is to further investigate and confirm the positive effects of PBMT on HNC-related chronic lymphedema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM A: PBMT12 | Active comparator | Device: LTU-904 Portable Laser Therapy Unit (active laser device), Device: LTU-904 Portable Laser Therapy Unit (sham/inactive laser device)After completion of the baseline measures, participants in ARM A will be scheduled for PBMT twice a week for 6 weeks followed by sham therapy once per week for 6 weeks (a total of 18 sessions: 12 PBMT and 6 sham therapy sessions). |
| ARM B: PBMT18 | Active comparator | Device: LTU-904 Portable Laser Therapy Unit (active laser device)After completion of the baseline measures, participants in ARM B will be scheduled for PBMT twice a week for 6 weeks followed by PBMT once per week for 6 weeks (a total of 18 PBMT sessions). |
| ARM C: Placebo | Sham comparator | Device: LTU-904 Portable Laser Therapy Unit (sham/inactive laser device)After completion of the baseline measures, participants in ARM C will receive sham therapy, twice a week for 6 weeks followed by sham therapy once per week for 6 weeks (a total of 18 sham therapy sessions). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 years of age Biopsy proven head and neck cancer No evidence of cancer at the time of study enrollment, between 12- and 60-month post-cancer treatment Chronic lymphedema (defined as lymphedema persisting for a minimum of 6 months) A minimum of 2 sites of external lymphedema At least 1 site with lymphedema of moderate severity as assessed using the HN-LEF Assessment Criteria Failed lymphedema therapy (defined as any of the following: incomplete response to therapy, progression of lymphedema after therapy, inability to perform effective self-care resulting in fluid re-accumulation; and inability to complete treatment due to systems barriers). In addition, patients must be able to understand English in order to complete questionnaires; and to provide informed consent.
Key exclusion criteria (2 listed)
- Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of PBMT:
- Women of childbearing age and potential Acute cellulitis within the soft tissues in the head and neck region Chronic inflammatory diseases Venous thrombosis Carotid artery stenosis Requiring ongoing use of diuretics and corticosteroids Pre-existing skin rash, ulceration, open wound in the treatment area Active lymphedema or physical therapy (including hyperbaric oxygen or trental) Allergic and other systemic skin diseases
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 |
|---|---|---|
| LTU-904 Portable Laser Therapy Unit (active laser device)The RianCorp LTU-904 laser therapy unit (active laser device) will be used for photobiomodulation therapy (PBMT). | Device | ARM A: PBMT12, ARM B: PBMT18 |
| LTU-904 Portable Laser Therapy Unit (sham/inactive laser device)The RianCorp LTU-904 laser therapy (sham/inactive laser device) unit will be used for sham therapy. | Device | ARM A: PBMT12, ARM C: Placebo |
Primary outcome
Total Severity of External Lymphedema
Time frame: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
Head and Neck Lymphedema and Fibrosis Assessment Criteria. External lymphedema is measured by HN-LEF Assessment Criteria. The total external lymphedema severity score is calculated by summing the severity score of each site (total 9 sites, severity score ranging from 0-27). For each site, the severity of LEF includes no lymphedema (=0), mild (=1), moderate (=2), and severe (=3). Change in total severity of external lymphedema from baseline to 12-month post-intervention visits. A larger reduction in this score means more reduction in the severity of external lymphedema.
6 secondary outcomes
Total Severity of Internal Lymphedema
Time frame: Pre-intervention, after 18 sessions (end-of-intervention), 12-month post-intervention
Symptom Burden Score
Time frame: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
Jaw Range of Motion Degree
Time frame: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
Neck Range of Motion Degree
Time frame: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
Shoulder Range of Motion Degree
Time frame: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
Quality of Life Score
Time frame: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention
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 23 Jun 2026.
- 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.
Sarah Latimore, MS contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LTU-904 Portable Laser Therapy Unit (active laser device) in people with Head and Neck Cancer and Lymphedema of the Head and Neck, run by Abramson Cancer Center at Penn Medicine at 2 sites 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Jie Deng, PhD (2155732393, jiedeng@nursing.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Severity of External Lymphedema (time frame: Pre-intervention, after 12 sessions, after 18 sessions (end-of-intervention), 3-, 6-, 9-and 12-month post-intervention). 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 23 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.