Photobiomodulation to reduce lymphedema and fibrosis after head and neck radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Kenneth Hu — NYU Langone Health
• Study coordinator: Kenneth Hu
• Email: Kenneth.Hu@nyulangone.org
• Phone: 212-731-5880

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.