Photobiomodulation with Light-Emitting Diode Therapy for Improvement of Radiation Fibrosis Syndrome in Patients with Head and Neck Cancer, PBM-LEF Trial

Inclusion Criteria

• Males or females aged 18 years or older
• Patients treated with radiation for head and neck cancer who are ≥ 3 months =< 36 months post-radiation therapy (RT) (last RT)
• Patients who received at least 50 grey (Gy) to the unilateral or bilateral neck. Subjects who received RT or concurrent chemoradiation (chemoRT) therapy for head and neck cancer (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

• Females 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 lymphedema and fibrosis (LEF)
• Patients without the capacity to consent
• 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