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

Mucositis Clinical Trial

Official title:

L-lysine in the Treatment of Oral Mucositis in Head and Neck Cancer Patients- A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155609
• Other study ID #: 7101
• Secondary ID: NCI-2010-01425
• Status: Completed
• Phase: N/A
• First received: June 29, 2010
• Last updated: May 15, 2013
• Start date: September 2010
• Est. completion date: October 2012

Study information

• Verified date: May 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Adenoid Cystic
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Laryngeal Diseases
• Laryngeal Neoplasms
• Mucositis
• Nasopharyngeal Neoplasms
• Oral Complications of Chemotherapy
• Oral Complications of Radiation Therapy
• Oropharyngeal Neoplasms
• 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
• Recurrent Squamous Cell Carcinoma of the Larynx
• Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
• Recurrent Squamous Cell Carcinoma of the Nasopharynx
• Recurrent Squamous Cell Carcinoma of the Oropharynx
• Recurrent Verrucous Carcinoma of the Larynx
• Recurrent Verrucous Carcinoma of the Oral Cavity
• Salivary Gland Neoplasms
• Stage I Adenoid Cystic Carcinoma of the Oral Cavity
• Stage I Basal Cell Carcinoma of the Lip
• Stage I Lymphoepithelioma of the Nasopharynx
• Stage I Lymphoepithelioma of the Oropharynx
• Stage I Mucoepidermoid Carcinoma of the Oral Cavity
• Stage I Salivary Gland Cancer
• Stage I Squamous Cell Carcinoma of the Hypopharynx
• Stage I Squamous Cell Carcinoma of the Larynx
• Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage I Squamous Cell Carcinoma of the Nasopharynx
• Stage I Squamous Cell Carcinoma of the Oropharynx
• Stage I Verrucous Carcinoma of the Larynx
• Stage I Verrucous Carcinoma of the Oral Cavity
• Stage II Adenoid Cystic Carcinoma of the Oral Cavity
• Stage II Basal Cell Carcinoma of the Lip
• Stage II Lymphoepithelioma of the Nasopharynx
• Stage II Lymphoepithelioma of the Oropharynx
• Stage II Mucoepidermoid Carcinoma of the Oral Cavity
• Stage II Salivary Gland Cancer
• Stage II Squamous Cell Carcinoma of the Hypopharynx
• Stage II Squamous Cell Carcinoma of the Larynx
• Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage II Squamous Cell Carcinoma of the Nasopharynx
• Stage II Squamous Cell Carcinoma of the Oropharynx
• Stage II Verrucous Carcinoma of the Larynx
• Stage II Verrucous Carcinoma of the Oral Cavity
• Stage III Adenoid Cystic Carcinoma of the Oral Cavity
• Stage III Basal Cell Carcinoma of the Lip
• Stage III Lymphoepithelioma of the Nasopharynx
• Stage III Lymphoepithelioma of the Oropharynx
• Stage III Mucoepidermoid Carcinoma of the Oral Cavity
• Stage III Salivary Gland Cancer
• Stage III Squamous Cell Carcinoma of the Hypopharynx
• Stage III Squamous Cell Carcinoma of the Larynx
• Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage III Squamous Cell Carcinoma of the Nasopharynx
• Stage III Squamous Cell Carcinoma of the Oropharynx
• Stage III Verrucous Carcinoma of the Larynx
• Stage III Verrucous Carcinoma of the Oral Cavity
• Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
• Stage IV Basal Cell Carcinoma of the Lip
• Stage IV Lymphoepithelioma of the Nasopharynx
• Stage IV Lymphoepithelioma of the Oropharynx
• Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
• Stage IV Salivary Gland Cancer
• Stage IV Squamous Cell Carcinoma of the Hypopharynx
• Stage IV Squamous Cell Carcinoma of the Larynx
• Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IV Squamous Cell Carcinoma of the Nasopharynx
• Stage IV Squamous Cell Carcinoma of the Oropharynx
• Stage IV Verrucous Carcinoma of the Larynx
• Stage IV Verrucous Carcinoma of the Oral Cavity
• Stomatitis

Intervention

Procedure:
• quality-of-life assessment
Ancillary studies
• management of therapy complications
Discontinue supplement; treat symptomatically

Dietary Supplement:
• L-lysine
Given PO

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in mucositis severity and time to complete response	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%.	Weekly post-treatment until Grade 0 mucositis is achieved	No
Secondary	Improvement in quality of life		Weekly post-treatment until Grade 0 mucositis is achieved	No