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

University of Washington

Status: Completed

Conditions: Recurrent Squamous Cell Carcinoma of the Hypopharynx; Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Lymphoepithelioma of the Oropharynx; Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity; Mucositis; Stage III Adenoid Cystic Carcinoma of the Oral Cavity; Stage IV Squamous Cell Carcinoma of the Oropharynx; Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity; Oral Complications of Chemotherapy; Recurrent Mucoepidermoid Carcinoma of the Oral Cavity; Recurrent Verrucous Carcinoma of the Larynx; Stage II Lymphoepithelioma of the Oropharynx; Stage II Salivary Gland Cancer; Stage II Verrucous Carcinoma of the Oral Cavity; Recurrent Squamous Cell Carcinoma of the Oropharynx; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage I Squamous Cell Carcinoma of the Hypopharynx; Stage II Squamous Cell Carcinoma of the Larynx; Oral Complications of Radiation Therapy; Stage I Lymphoepithelioma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage III Verrucous Carcinoma of the Oral Cavity; Stage II Squamous Cell Carcinoma of the Hypopharynx; Stage I Mucoepidermoid Carcinoma of the Oral Cavity; Stage III Mucoepidermoid Carcinoma of the Oral Cavity; Stage II Mucoepidermoid Carcinoma of the Oral Cavity; Stage I Verrucous Carcinoma of the Oral Cavity; Stage III Squamous Cell Carcinoma of the Oropharynx; Stage I Adenoid Cystic Carcinoma of the Oral Cavity; Stage IV Mucoepidermoid Carcinoma of the Oral Cavity; Stage II Adenoid Cystic Carcinoma of the Oral Cavity; Stage III Lymphoepithelioma of the Nasopharynx; Recurrent Lymphoepithelioma of the Nasopharynx; Stage III Squamous Cell Carcinoma of the Hypopharynx; Recurrent Salivary Gland Cancer; Stage IV Salivary Gland Cancer; Stage III Basal Cell Carcinoma of the Lip; Stage I Salivary Gland Cancer; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage II Basal Cell Carcinoma of the Lip; Recurrent Adenoid Cystic Carcinoma of the Oral Cavity; Stage I Verrucous Carcinoma of the Larynx; Recurrent Basal Cell Carcinoma of the Lip; Stage IV Adenoid Cystic Carcinoma of the Oral Cavity; Stage I Squamous Cell Carcinoma of the Nasopharynx; Stage IV Basal Cell Carcinoma of the Lip; Stage IV Squamous Cell Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Stage IV Lymphoepithelioma of the Nasopharynx; Recurrent Lymphoepithelioma of the Oropharynx; Stage I Squamous Cell Carcinoma of the Oropharynx; Stage IV Verrucous Carcinoma of the Larynx; Stage IV Verrucous Carcinoma of the Oral Cavity; Stage III Verrucous Carcinoma of the Larynx; Stage II Lymphoepithelioma of the Nasopharynx; Stage III Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Stage III Lymphoepithelioma of the Oropharynx; Stage II Verrucous Carcinoma of the Larynx; Stage I Squamous Cell Carcinoma of the Larynx; Stage II Squamous Cell Carcinoma of the Oropharynx; Stage I Basal Cell Carcinoma of the Lip; Stage III Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage II Squamous Cell Carcinoma of the Nasopharynx; Stage I Lymphoepithelioma of the Nasopharynx; Stage III Salivary Gland Cancer

Treatments: Procedure: management of therapy complications; Dietary Supplement: L-lysine; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01155609

7101

NCI-2010-01425 (Registry Identifier)

Details and patient eligibility

About

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 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Supportive care (oral complications management)

Experimental group

Description:

Patients receive L-Lysine PO QD until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity.

Treatment:

Procedure: quality-of-life assessment

Dietary Supplement: L-lysine

Procedure: management of therapy complications