Clinical Trials

Inclusion Criteria: 

• Squamous cell carcinoma of the head and neck.
• Treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy.
• Treatment plan to receive standard cisplatin monotherapy.
• Age 18 years or older.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Adequate hematologic, renal and liver function.
• Negative serum pregnancy test.
• Use of effective contraception.

Exclusion Criteria:

• Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands.
• Metastatic disease. 
• Prior radiotherapy to the region of the study cancer or adjacent anatomical. 
• Prior induction chemotherapy. 
• Receiving any approved or investigational anti-cancer agent other than those provided for in this study. 
• Concurrent participation in another interventional clinical study.
• Inability to eat soft solid food at baseline.
• Malignant tumors other than HNC within the last 5 years.
• Active infectious disease excluding oral candidiasis. 
• Presence of oral mucositis at baseline. 
• Known history of HIV or active hepatitis B/C.
• Female patients who are pregnant or breastfeeding. 
• Known allergies or intolerance to cisplatin and similar platinum-containing compounds. 
• Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure.