L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer
NCT ID: NCT01155609
Last Updated: 2013-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2010-09-30
2012-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
quality-of-life assessment
Ancillary studies
management of therapy complications
Discontinue supplement; treat symptomatically
L-lysine
Given PO
Interventions
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quality-of-life assessment
Ancillary studies
management of therapy complications
Discontinue supplement; treat symptomatically
L-lysine
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Upendra Parvathaneni
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2010-01425
Identifier Type: REGISTRY
Identifier Source: secondary_id
7101
Identifier Type: -
Identifier Source: org_study_id
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