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Brief Title: L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer
Official Title: L-lysine in the Treatment of Oral Mucositis in Head and Neck Cancer Patients- A Pilot Study
Study ID: NCT01155609
Brief Summary: 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
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States
Name: Upendra Parvathaneni
Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Role: PRINCIPAL_INVESTIGATOR