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

Inclusion criteria

• ✓. 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.

Exclusion criteria