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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

June 29, 2010
July 2, 2010
May 17, 2013
September 2010
December 2011   (Final data collection date for primary outcome measure)
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%.
Decrease in mucositis severity and time to complete response [ Time Frame: One month after final patient enrolled experiences complete resolution of mucositis ]
Complete list of historical versions of study NCT01155609 on ClinicalTrials.gov Archive Site
Improvement in quality of life [ Time Frame: Weekly post-treatment until Grade 0 mucositis is achieved ]
Improvement in quality of life [ Time Frame: One month after final patient enrolled completes final FLIC-Q ]
Not Provided
Not Provided
 
L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer
L-lysine in the Treatment of Oral Mucositis in Head and Neck Cancer Patients- A Pilot Study
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

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • 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
    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
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.
Interventions:
  • Procedure: quality-of-life assessment
  • Procedure: management of therapy complications
  • Dietary Supplement: L-lysine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
Same as current
October 2012
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01155609
7101
NCI-2010-01425 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
No
Not Provided
Not Provided
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Upendra Parvathaneni Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP