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

University of Washington10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Mucositis Oral Complications of Chemotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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%.

Time frame: Weekly post-treatment until Grade 0 mucositis is achieved

Secondary Outcomes

Improvement in quality of life