L-lysine in the Treatment of Oral Mucositis in Head and Neck Cancer Patients- A Pilot Study
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.
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.
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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Decrease in mucositis severity and time to complete response
Complete Response will be documented by complete resolution of oral mucositis, as defined by the Radiation Therapy Oncology Group (RTOG) grading scale. If the true percent of patients that respond is 20%, we will have a 90% chance of seeing at least 1 patient in 10 with a response. If none of the 10 patients show significant improvement in time to response, then we can be 90% confident that the true rate of significant improvement is less than 20%.
Weekly post-treatment until Grade 0 mucositis is achieved
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|