Radiation LymphedemaPBM-LEFNCT06708754
Impact of Photobiomodulation (PBM) on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients
A study testing Photobiomodulation (PBM) Therapy in people with Radiation Lymphedema and Radiation Fibrosis, run by NYU Langone Health at 1 site in United States.
Trial summary
Radiation fibrosis syndrome (RFS) is a general side effect of radiation therapy (RT) which can adversely impact patients chronically over years typically triggered by an acute inflammatory state that evolves into chronic inflammation and tissue remodeling causing lymphedema, fibrosis, pain, atrophy and organ… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Lymphedema, Radiation Fibrosis, Head and Neck Cancer
- What is being tested?
- Photobiomodulation (PBM) Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2025to 13 Feb 2030
- 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
- Patients treated with radiation for head and neck cancer who are ≥ 3 months < 36 months post-RT (last RT).
- Patients who received at least 50Gy of bilateral neck RT. Subjects who received RT or concurrent chemoradiation (chemoRT) therapy for HNC are eligible.
- No evidence of disease as documented by imaging 3 months after completion of RT.
- Common Terminology Criteria for Adverse Events (CTCAE) fibrosis score ≥ 2 at enrollment.
- Patient who has body mass index (BMI) >30 at the time of enrollment may be excluded at a discretion of the principal investigator if fibrotic areas cannot be identified by clinical objective assessment of fibrosis.
- Willing to comply with all study procedures and be available for the duration of the study.
Who cannot join
- Woman who are pregnant or planning to become pregnant or breast-feeding.
- Patients enrolled on another drug or device investigational trial for prevention or treatment of LEF.
- Patients deprived of freedom, under supervision or guardianship.
- Patients unable to attend to scheduled visits due to geographical, social or mental reasons.
- Patients who received prior PBM therapy for RT toxicities in the last year;
- Patients who report being photosensitive.
- Patients who have chronic immunosuppression or are on current immunosuppressive therapies.
- Any patient who, in the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cancer Trials Inbox contact
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: PBM-LEF Study: The Impact of PBM on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients: A Feasibility Study
Radiation fibrosis syndrome (RFS) is a general side effect of radiation therapy (RT) which can adversely impact patients chronically over years typically triggered by an acute inflammatory state that evolves into chronic inflammation and tissue remodeling causing lymphedema, fibrosis, pain, atrophy and organ dysfunction. Some of the side effects that encompass RFS in the head and neck (HNC) population include decreased ability to fully open the mouth (trismus), neck pain and tightness (cervical dystonia), lymphedema (swelling), difficult with speech and swallowing and salivary hypofunction. Although there is Level I evidence demonstrating the benefit of Photobiomodulation (PBM) therapy to prevent acute mucositis in HNC patients treated with RT, there is only limited data regarding its impact.
This is a clinical trial to compare active treatment (PBM-therapy) with sham control (Sham- therapy). Up to 60 patients will be randomized to the two groups with equal allocation to estimate the efficacy (soft tissue thickness) of external Photobiomodulation (PBM) with light-emitting diode (LED) planned therapy for the treatment of radiation fibrosis syndrome (RFS) in head and neck cancer (HNC) patients who have undergone radiation therapy (RT) compared with sham control.
- Being tested
- Photobiomodulation (PBM) Therapy, Sham PBM
- Medical subject headings
- Radiation Fibrosis Syndrome, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation (PBM) TherapyDevice
PBM is a low-intensity form of light therapy and employs visible or near-infrared (NIR) light generated from a laser or Light Emitting Diode (LED).
In this study, PBM will be delivered using an LED device emitting 660 and 850nm with the purpose of research. The output power typically ranges from 5 to 200 mW with wavelengths ranging 600-1,000nm.
Sham PBMDevice
Sham PBM will be delivered using a matching shame device that emits no output power.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment: PBM Therapy | Experimental | Participants who received bilateral neck RT will be treated with PBM to a total of 12 sites - 6 sites on each side of the neck and face along the 3 neck nodal levels (II, III, IV) of the sternocleidomastoid muscle (SCM), along the major salivary glands (parotid, and submandibular) and masseter].
Treatment will occur at two timepoints:
* At least 3 months and less than 18 months after RT completion of last dose to any site
* Between 18 and 36 months after RT completion of last dose to any site Receives: Device: Photobiomodulation (PBM) Therapy |
| Sham Treatment | Sham comparator | Participants who received bilateral neck RT will be treated with SHAM PBM to a total of 12 sites - 6 sites on each side of the neck and face along the 3 neck nodal levels (II, III, IV) of the sternocleidomastoid muscle (SCM), along the major salivary glands (parotid, and submandibular) and masseter].
Treatment will occur at two timepoints:
* At least 3 months and less than 18 months after RT completion of last dose to any site
* Between 18 and 36 months after RT completion of last dose to any site Receives: Device: Sham PBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue thickness (STT) at Nodal Level II - Right Side
STT will be measured via ultrasound.
Measured: Baseline, Week 2 Post-Treatment
STT at Nodal Level II - Left Side
STT will be measured via ultrasound.
Measured: Baseline, Week 2 Post-Treatment
STT at Nodal Level III - Right Side
STT will be measured via ultrasound.
Measured: Baseline, Week 2 Post-Treatment
STT at Nodal Level III - Left Side
STT will be measured via ultrasound.
Measured: Baseline, Week 2 Post-Treatment
STT at Nodal Level IV - Right Side
STT will be measured via ultrasound.
Measured: Baseline, Week 2 Post-Treatment
STT at Nodal Level IV - Left Side
STT will be measured via ultrasound.
Measured: Baseline, Week 2 Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start13 Feb 2025
- Primary completion13 Feb 2028 (estimated)
- Study completion13 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation LymphedemaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Hu, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708754
- Sponsor's protocol ID
- 19-00511
- Acronym
- PBM-LEF
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PBM-LEF Study: The Impact of PBM on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06708754
- Acronym / sponsor ID
- PBM-LEF / 19-00511
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 13 Feb 2028 (estimated)
- Study completion
- 13 Feb 2030 (estimated)
- First posted
- 27 Nov 2024 (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.
Radiation fibrosis syndrome (RFS) is a general side effect of radiation therapy (RT) which can adversely impact patients chronically over years typically triggered by an acute inflammatory state that evolves into chronic inflammation and tissue remodeling causing lymphedema, fibrosis, pain, atrophy and organ dysfunction. Some of the side effects that encompass RFS in the head and neck (HNC) population include decreased ability to fully open the mouth (trismus), neck pain and tightness (cervical dystonia), lymphedema (swelling), difficult with speech and swallowing and salivary hypofunction. Although there is Level I evidence demonstrating the benefit of Photobiomodulation (PBM) therapy to prevent acute mucositis in HNC patients treated with RT, there is only limited data regarding its impact.
This is a clinical trial to compare active treatment (PBM-therapy) with sham control (Sham- therapy). Up to 60 patients will be randomized to the two groups with equal allocation to estimate the efficacy (soft tissue thickness) of external Photobiomodulation (PBM) with light-emitting diode (LED) planned therapy for the treatment of radiation fibrosis syndrome (RFS) in head and neck cancer (HNC) patients who have undergone radiation therapy (RT) compared with sham control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment: PBM Therapy | Experimental | Device: Photobiomodulation (PBM) TherapyParticipants who received bilateral neck RT will be treated with PBM to a total of 12 sites - 6 sites on each side of the neck and face along the 3 neck nodal levels (II, III, IV) of the sternocleidomastoid muscle (SCM), along the major salivary glands (parotid, and submandibular) and masseter]. Treatment will occur at two timepoints: * At least 3 months and less than 18 months after RT completion of last dose to any site * Between 18 and 36 months after RT completion of last dose to any site |
| Sham Treatment | Sham comparator | Device: Sham PBMParticipants who received bilateral neck RT will be treated with SHAM PBM to a total of 12 sites - 6 sites on each side of the neck and face along the 3 neck nodal levels (II, III, IV) of the sternocleidomastoid muscle (SCM), along the major salivary glands (parotid, and submandibular) and masseter]. Treatment will occur at two timepoints: * At least 3 months and less than 18 months after RT completion of last dose to any site * Between 18 and 36 months after RT completion of last dose to any site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients treated with radiation for head and neck cancer who are ≥ 3 months < 36 months post-RT (last RT).
- Patients who received at least 50Gy of bilateral neck RT. Subjects who received RT or concurrent chemoradiation (chemoRT) therapy for HNC are eligible.
- No evidence of disease as documented by imaging 3 months after completion of RT.
- Common Terminology Criteria for Adverse Events (CTCAE) fibrosis score ≥ 2 at enrollment.
- Patient who has body mass index (BMI) >30 at the time of enrollment may be excluded at a discretion of the principal investigator if fibrotic areas cannot be identified by clinical objective assessment of fibrosis.
Key exclusion criteria (8 listed)
- Woman who are pregnant or planning to become pregnant or breast-feeding.
- Patients enrolled on another drug or device investigational trial for prevention or treatment of LEF.
- Patients deprived of freedom, under supervision or guardianship.
- Patients unable to attend to scheduled visits due to geographical, social or mental reasons.
- Patients who received prior PBM therapy for RT toxicities in the last year;
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 |
|---|---|---|
| Photobiomodulation (PBM) TherapyPBM is a low-intensity form of light therapy and employs visible or near-infrared (NIR) light generated from a laser or Light Emitting Diode (LED). In this study, PBM will be delivered using an LED device emitting 660 and 850nm with the purpose of research. The output power typically ranges from 5 to 200 mW with wavelengths ranging 600-1,000nm. | Device | Active Treatment: PBM Therapy |
| Sham PBMSham PBM will be delivered using a matching shame device that emits no output power. | Device | Sham Treatment |
Primary outcome
Soft tissue thickness (STT) at Nodal Level II - Right Side
Time frame: Baseline, Week 2 Post-Treatment
STT will be measured via ultrasound.
STT at Nodal Level II - Left Side
Time frame: Baseline, Week 2 Post-Treatment
STT will be measured via ultrasound.
STT at Nodal Level III - Right Side
Time frame: Baseline, Week 2 Post-Treatment
STT will be measured via ultrasound.
STT at Nodal Level III - Left Side
Time frame: Baseline, Week 2 Post-Treatment
STT will be measured via ultrasound.
STT at Nodal Level IV - Right Side
Time frame: Baseline, Week 2 Post-Treatment
STT will be measured via ultrasound.
STT at Nodal Level IV - Left Side
Time frame: Baseline, Week 2 Post-Treatment
STT will be measured via ultrasound.
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 30 Mar 2026.
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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.
Cancer Trials Inbox contact
Kenneth Hu principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation (PBM) Therapy in people with Radiation Lymphedema and Radiation Fibrosis, run by NYU Langone Health 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 6 inclusion and 8 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 30 Mar 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. 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 Kenneth Hu (212-731-5880, Kenneth.Hu@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue thickness (STT) at Nodal Level II - Right Side (time frame: Baseline, Week 2 Post-Treatment). The study lists 6 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 30 Mar 2026.