Mucositis Clinical Trial
Official title:
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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