L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer

L-lysine in the Treatment of Oral Mucositis in Head and Neck Cancer Patients- A Pilot Study

This pilot clinical trial studies L-lysine in treating oral mucositis in patients undergoing radiation therapy with or without chemotherapy for head and neck cancer. L-lysine may lessen the severity of oral mucositis, or mouth sores in patients receiving radiation therapy with or without chemotherapy for head and neck cancer

PRIMARY OBJECTIVES:

I. To determine the complete response rate, decrease in severity, and time to complete response of oral mucositis related to head and neck cancer irradiation and chemotherapy after using L-lysine supplementation daily.

SECONDARY OBJECTIVES:

I. To determine the functional impact of use of L-lysine for oral mucositis on daily life as measured by the Functional Life Index-Cancer (FLIC) Questionnaire total score.

OUTLINE:

Patients receive L-lysine orally (PO) once daily (QD) until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up weekly until mucositis resolves.

Inclusion Criteria:

• Cytologically or pathologically proven cancer of the oropharynx, lip, oral cavity, larynx, hypopharynx, nasopharynx, and salivary glands
• Predicted life expectancy greater than 12 weeks
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Renal function with a calculated creatinine clearance of 55 ml/min or greater, per Cockcroft-Gault formula
• Patients undergoing radiation therapy with or without concurrent chemotherapy
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Use of illicit drugs, alcohol abuse, or tobacco abuse during treatment
• Subjects may not be receiving other investigational agents
• Inability or unwillingness to comply with radiation therapy and chemotherapy regimens
• Inability or unwillingness to take daily L-Lysine supplementation as prescribed
• Use of arginine supplementation
• History of renal failure or compromise