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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Washington

Current Primary Outcome: Decrease in mucositis severity and time to complete response [ Time Frame: Weekly post-treatment until Grade 0 mucositis is achieved ]

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%.


Original Primary Outcome: Decrease in mucositis severity and time to complete response [ Time Frame: One month after final patient enrolled experiences complete resolution of mucositis ]

Current Secondary Outcome: Improvement in quality of life [ Time Frame: Weekly post-treatment until Grade 0 mucositis is achieved ]

Original Secondary Outcome: Improvement in quality of life [ Time Frame: One month after final patient enrolled completes final FLIC-Q ]

Information By: University of Washington

Dates:
Date Received: June 29, 2010
Date Started: September 2010
Date Completion:
Last Updated: May 15, 2013
Last Verified: May 2013