NCT06708754 · NYU Langone Health
Impact of Photobiomodulation (PBM) on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients
(PBM-LEF)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Photobiomodulation (PBM) Therapy
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.
DEVICE
Sham PBM
Sham PBM will be delivered using a matching shame device that emits no output power.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations