Clinical trial · Interventional
Effect of Arginine- and Glutamine-based Oral Formulations on Salivary Biomarkers and Clinical Severity of Radiation-induced Oral Mucositis in Head and Neck Cancer: A Randomized Controlled Trial
- 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 triple-blinded, randomized controlled clinical trial investigates the effectiveness of L-arginine and L-glutamine oral suspensions in managing radiation-induced oral mucositis (RIOM) in patients with head and neck cancer (HNC) undergoing radiotherapy. A total of 69 patients are randomly assigned to three groups: L-arginine + maltodextrin, glutamine + maltodextrin, or maltodextrin alone (control). The interventions are administered as a swish-and-swallow solution three times daily from the second to seventh week of radiotherapy. Key outcomes assessed include oral mucositis severity (WHO scale), pain intensity (VAS), body mass index (BMI), oral health-related quality of life (OHIP-14), and salivary epidermal growth factor (EGF) levels. The study aims to determine whether L-arginine offers superior mucosal healing and symptom relief compared to glutamine or placebo.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
| Oral Mucositis Due to Radiation | — | UNRESOLVED | — |
| Radiation Induced Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| L-arginine Oral Suspension | Dietary Supplement | — | UNRESOLVED |
| L-glutamine Oral Suspension | Dietary Supplement | — | UNRESOLVED |
| Maltodextrin Oral Suspension (Control) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group I - L-arginine + Maltodextrin Oral Suspension
- description
- Patients receive 5 g of L-arginine + 5 g of maltodextrin dissolved in cold distilled water.
- interventionNames
- Dietary Supplement: L-arginine Oral Suspension
- type
- ACTIVE_COMPARATOR
- label
- Group II - Glutamine + Maltodextrin Oral Suspension
- description
- Group II - Glutamine + Maltodextrin Oral Suspension
- interventionNames
- Dietary Supplement: L-glutamine Oral Suspension
- type
- PLACEBO_COMPARATOR
- label
- Group III - Maltodextrin Oral Suspension (Control Group)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 20 and 70 years Diagnosed with head and neck cancer (HNC) and undergoing radiotherapy (RT) Development of oral mucositis during the 2nd to 3rd week of RT Receiving a minimum radiation dose of 50 Gy to the oral cavity Undergoing intensity-modulated radiotherapy (IMRT) with three-dimensional conformal techniques after complete tumor resection Ability and willingness to provide informed consent Able to comply with study procedures and follow-up assessments Exclusion Criteria: * History of prior radiotherapy Diagnosed with diabetes mellitus Presence of salivary gland tumors Renal or hepatic insufficiency Sepsis or any active systemic infection Distant metastases Any condition that may interfere with oral sample collection or affect EGF levels (e.g., autoimmune oral disease)
References
Publications (1)
- DERIVEDHassanein FEA, Ahmed DE, Elkot S, Abou-Bakr A. Nutritional Amino Acid Supplementation Reduces Severity and Enhances Recovery of Radiation-Induced Oral Mucositis: A Triple-Blind Randomized Clinical Trial. J Oral Rehabil. 2026 Jun 25. doi: 10.1111/joor.70246. Online ahead of print. PMID 42347702