Status:
COMPLETED
L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Mucositis
Oral Complications of Chemotherapy
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
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 afte...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01155609
Start Date
September 1 2010
End Date
October 1 2012
Last Update
May 17 2013
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109