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

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ClinicalTrials.gov Identifier: NCT01155609
Recruitment Status : Completed
First Posted : July 2, 2010
Last Update Posted : May 17, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Study Description
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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

Condition or disease Intervention/treatment Phase
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 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 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 Procedure: quality-of-life assessment Procedure: management of therapy complications Dietary Supplement: L-lysine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: L-lysine in the Treatment of Oral Mucositis in Head and Neck Cancer Patients- A Pilot Study
Study Start Date : September 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : October 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Procedure: management of therapy complications
Discontinue supplement; treat symptomatically
Other Name: complications of therapy, management of

Dietary Supplement: L-lysine
Given PO
Other Names:
  • L-lysine monohydrate
  • lysine monohydrate


Outcome Measures
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Primary Outcome Measures :
  1. Decrease in mucositis severity and time to complete response [ Time Frame: 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 :
  1. Improvement in quality of life [ Time Frame: Weekly post-treatment until Grade 0 mucositis is achieved ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155609


Locations
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United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Upendra Parvathaneni Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
More Information
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01155609    
Other Study ID Numbers: 7101
NCI-2010-01425 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Carcinoma, Verrucous
Carcinoma, Basal Cell
Salivary Gland Neoplasms
Nasopharyngeal Carcinoma
Carcinoma, Adenoid Cystic
Carcinoma, Mucoepidermoid
Mucositis
Stomatitis
Laryngeal Diseases
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Respiratory Tract Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Pharyngeal Diseases