Photobiomodulation to reduce lymphedema and fibrosis after head and neck radiation

PBM-LEF Study: The Impact of PBM on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients: A Feasibility Study

We will try photobiomodulation (low‑level light) therapy to reduce lymphedema and fibrosis in people who finished head and neck radiation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (New York, New York)
• Trial ID: NCT06708754 on ClinicalTrials.gov

What this trial studies

This randomized, sham‑controlled study will enroll up to 60 head and neck cancer survivors 3–36 months after completing radiation who have at least grade 2 radiation fibrosis. Participants will be randomly assigned to active photobiomodulation (PBM) therapy or a sham PBM device with equal allocation. The trial will collect biological markers and measure clinical signs of lymphedema, fibrosis, pain, mouth opening, neck mobility, and swallowing over time to see if PBM produces measurable biological and functional improvements. Regular treatment sessions and follow-up visits will track both short‑term and longer‑term changes.

Who should consider this trial

Good fit: Ideal candidates are head and neck cancer survivors 3–36 months after completing bilateral neck radiation of at least 50 Gy, with no evidence of disease and a CTCAE fibrosis score ≥2 who can attend study visits.

Not a fit: Patients who are pregnant or breastfeeding, enrolled in another investigational LEF trial, have unclear fibrotic targets due to high BMI, have active disease, or cannot travel to the study site may not benefit or be eligible.

Why it matters

Potential benefit: If successful, PBM could lessen lymphedema and fibrosis, reduce pain, and improve mouth opening, neck mobility, swallowing, and overall quality of life for survivors.

How similar studies have performed: High‑quality evidence shows PBM prevents acute mucositis in head and neck radiation patients, but evidence for treating chronic radiation fibrosis and lymphedema is limited and largely exploratory.

Eligibility criteria

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 this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Kenneth Hu — NYU Langone Health
• Study coordinator: Kenneth Hu

Conditions Radiation Lymphedema; Radiation Fibrosis; Head and Neck Cancer