MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients

Inclusion Criteria: * Histologically confirmed HNSCC (The American joint committee on cancer \[AJCC\] 8th edition, Stage II, III, IVA, or IVB), involving either the oral cavity or oropharynx, or HPV-positive Stage I oropharyngeal cancer. * Treatment plan to receive a continuous course of intensity-modulated radiation therapy (IMRT) for definitive treatment of HNSCC delivered as single daily fractions of 1.8 to 2.5 Gy with a cumulative radiation dose between 60 and 72 Gy (EQD2 of 60 to 72 Gy, α/β ratio=10): Planned radiation treatment fields must include at least 30% of oral cavity that are planned to receive a total of 50 Gy or higher. * CCRT plan to receive standard cisplatin monotherapy: Standard cisplatin monotherapy administered weekly (30 to 40 mg/m2), once per week for 5 to 7 continuous weeks. * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 1 or less * Serum pregnancy test negative for women of childbearing potential (woman of childbearing potential \[WOCBP\] Exclusion Criteria: * Patients who have active mucositis at screening. * Planned to receive Erbitux™ (Cetuximab) or other targeted or immune therapy during the study. * Tumor of the lips, sinuses, or salivary glands or unknown primary tumors. * Metastatic disease (M1) Stage. * Known history of severe vascular toxicity or allergies or intolerance to cisplatin and similar platinum-containing compounds. * Any clinically significant and/or active infection, other systemic illness or condition (other than HNSCC) that would preclude them from participating in the study in the opinion of the Investigator. * Prior resective surgery (4 weeks or less than 4 weeks from receiving surgery to randomization) for primary tumor under treatment for HNSCC.