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

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

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.

Interventions

  • Procedure: quality-of-life assessment
    • Ancillary studies
  • Procedure: management of therapy complications
    • Discontinue supplement; treat symptomatically
  • Dietary Supplement: L-lysine
    • Given PO

Arms, Groups and Cohorts

  • Experimental: Supportive care (oral complications management)
    • Patients receive L-Lysine PO QD until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity.

Clinical Trial Outcome Measures

Primary Measures

  • 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%.

Secondary Measures

  • Improvement in quality of life
    • Time Frame: Weekly post-treatment until Grade 0 mucositis is achieved

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Upendra Parvathaneni, Principal Investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

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