Clinical trial · Interventional
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
NCT01155609CI-TRIAL-00010351completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (68)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucositis | — | UNRESOLVED | — |
| Oral Complications of Chemotherapy | — | UNRESOLVED | — |
| Oral Complications of Radiation Therapy | — | UNRESOLVED | — |
| Recurrent Adenoid Cystic Carcinoma of the Oral Cavity | Oral Cavity Adenoid Cystic Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Basal Cell Carcinoma of the Lip | Lip Basal Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Lymphoepithelioma of the Nasopharynx | Nasopharyngeal Undifferentiated Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Lymphoepithelioma of the Oropharynx | — | UNRESOLVED | — |
| Recurrent Mucoepidermoid Carcinoma of the Oral Cavity | Oral Cavity Mucoepidermoid Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Salivary Gland Cancer |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| L-lysine | Dietary Supplement | — | UNRESOLVED |
| management of therapy complications | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (oral complications management)
- description
- Patients receive L-Lysine PO QD until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Procedure: quality-of-life assessment
- Procedure: management of therapy complications
- Dietary Supplement: L-lysine
Primary outcomes (1)
- measure
- Decrease in mucositis severity and time to complete response
- timeFrame
- Weekly post-treatment until Grade 0 mucositis is achieved
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.