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

Not Applicable

Completed

• Conditions: Mucositis; Oral Complications of Chemotherapy; Oral Complications of Radiation Therapy; Recurrent Adenoid Cystic Carcinoma of the Oral Cavity; Recurrent Basal Cell Carcinoma of the Lip; Recurrent Lymphoepithelioma of the Nasopharynx; Recurrent Lymphoepithelioma of the Oropharynx; Recurrent Mucoepidermoid Carcinoma of the Oral Cavity; Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx
• Interventions: Procedure: quality-of-life assessment; Procedure: management of therapy complications; Dietary Supplement: L-lysine

• Registration Number: NCT01155609
• Lead Sponsor: University of Washington

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 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.

Study Timeline

• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-02
• Study Start: 2010-09
• Primary Completion: 2011-12
• Study Completion: 2012-10
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-15
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (oral complications management)	quality-of-life assessment	Patients receive L-Lysine PO QD until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity.
Supportive care (oral complications management)	management of therapy complications	Patients receive L-Lysine PO QD until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity.
Supportive care (oral complications management)	L-lysine	Patients receive L-Lysine PO QD until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Decrease in mucositis severity and time to complete response	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 Outcome Measures

Name	Time	Method
Improvement in quality of life	Weekly post-treatment until Grade 0 mucositis is achieved

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States