Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients

Prior treatment

• Subject is currently receiving or has previously received chemotherapy or chemoradiotherapy within the past 2 years and the oral cavity has not yet fully recovered.
• Subject is given neo-adjuvant or induction chemotherapy for Head and Neck cancer prior to starting RT.
• Subject is receiving medications indicated for the treatment and/or prevention of mucositis (e.g., palifermin).
• Subject has had prior radiation to the head and neck.
• Subject has an active infection in the oropharynx and/or oral cavity (any infection in the oropharynx and/or oral cavity at the time of screening must be addressed prior to first radiation treatment).
• Subject is receiving, or has received in the last 30 days, an investigational treatment, therapy, or medical device outside of this clinical study protocol.
• Subject has a Baseline mouth pain score of greater than 5 out of 10 on question 6 of the OMWQ-HN. Exception can be made if Principal Investigator determines the cause of mouth pain is due to tumor or surgery site pain.
• Subject is unable to participate in the study because of a concurrent or recent disease state that, in the opinion of the Principal Investigator, would affect the study endpoints, e.g., dental disease or COVID-19 (active or recovered).
• Subject has 8 or more dental prostheses or implants.
• Subject is not considered eligible at the discretion of the oral maxillofacial dentist/surgeon. Exception can be made if all items identified on the dental exam have been addressed prior to first radiation treatment.
• Subject is receiving any medications with oral photoprotection indications.

Other illness

• Subject has been diagnosed with another type/site of cancer that has not been controlled.
• Subject has a diagnosis that is prone to affect wound healing, e.g., uncontrolled diabetes.
• Subject has a salivary disturbance, e.g., Sjögren's syndrome.

Other

• Subject is pregnant or nursing.
• Subject has trismus with an interincisal distance of 30mm or less.
• Subject has any grade of oral mucositis per WHO Oral Toxicity Scale.

• Subject has been diagnosed with pathologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, tonsil or base of tongue.
• Within 28 days of Screening, subject is scheduled to receive a continuous course of Intensity-Modulated Radiation Therapy (IMRT) over an estimated 6 to 8 weeks (treatment week is defined as 5 fractions per week). The initial target volume encompassing the gross and subclinical disease sites will receive 5 fractions per week with a minimum cumulative dose of 50 Gray (Gy) for low to intermediate risk (sites of suspected subclinical spread) and maximum cumulative dose of 70 Gy for gross tumor volume/High risk (Primary tumor and involved lymph nodes).
• The subject's planned radiation treatment fields include a minimum of 50 Gy to at least two oral cavity sites (i.e. buccal mucosa, floor of mouth, ventral tongue, lateral tongue, dorsal tongue, hard palate, and soft palate).
• If the subject is receiving concurrent chemotherapy, the treatment plan includes Cisplatin administered in either a standard weekly (30-40 mg/m2) or approximately every 21 days (80-100mg/m2) regimen OR Carboplatin administered in standard weekly (1.0-2.0 AUC) regimen WITH/WITHOUT Paclitaxel administered in a standard weekly (30-45mg/m2) regimen.
• Subject is at least 22 years of age.
• Subject has no dental or oral health conditions that would preclude daily use of a mouthpiece and demonstrates capability in sustaining mouthpiece in oral cavity for recommended time during Screening procedure.
• Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
• Subject is able to read and understand the Informed Consent Form (ICF) and has voluntarily provided written informed consent.
• For the entire duration of their treatment, the subject will not use any tobacco or nicotine products with the exception of nicotine patches.
• For the entire duration of their treatment, the subject will not use any inhaled cannabis products or any illicit drugs.