Clinical trial · Interventional
Effect of Arginine and Glutamine on Radiation-induced Oral Mucositis: a Trible Blinded Randomized Controlled Clinical 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)
Oral Mucositis (OM) is a painful inflammation and ulceration of the oral mucosa, often resulting from cancer treatments like chemotherapy and radiation therapy, particularly in head and neck cancer patients. This condition is highly prevalent, affecting up to 40% of patients undergoing conventional chemotherapy, 80% of those receiving high-dose chemotherapy before hematopoietic stem cell transplantation, and nearly all patients undergoing radiation therapy for head and neck cancers. OM develops in four phases: inflammatory/vascular, epithelial, ulcerative/bacteriological, and wound healing. The initial phase involves damage to DNA and basal epithelial cells due to free radicals and reactive oxygen species (ROS) produced by treatments. This damage leads to a cascade of inflammatory reactions, resulting in visible lesions and bacterial colonization in the subsequent stages. Glutamine, an amino acid abundant in human blood, plays a crucial role in cellular repair, immune function, and muscle maintenance. It is a preferred energy source for lymphocytes and the gastrointestinal tract, aiding in mucosal healing and resistance to infections. Studies suggest that glutamine supplementation can reduce the toxic effects of radiation on the GI tract and improve mucosal healing by supporting immune cells and reducing inflammation. L-arginine, another amino acid, contributes to protein synthesis, nitric oxide production, and regulation of various physiological functions. It has been shown to decrease intestinal inflammation and oxidative stress, promoting mucosal immune homeostasis. L-arginine administration has demonstrated beneficial effects in reducing intestinal injury and inflammation in experimental models. The study proposes evaluating the combined effect of arginine and glutamine on radiation-induced mucositis in head and neck cancer patients. The primary objective is to assess the clinical efficacy of an oral suspension of these amino acids using the WHO Oral Toxicity Scale. Secondary objectives include evaluating pain and mucositis severity using assessment scales. The hypothesis is that arginine and glutamine supplementation may reduce mucositis severity and improve clinical outcomes, potentially leading to better nutritional status, enhanced survival, and reduced complications in cancer patients. This study aims to fill the gap in existing research by investigating the synergistic effects of these amino acids in managing radiation-induced mucositis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiation Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arginine and Glutamine Oral Suspension | Dietary Supplement | — | UNRESOLVED |
| Glutamine Oral Suspension | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- This group includes twenty patients receiving a combined oral suspension of 5 grams of arginine and 5 grams of glutamine dissolved in cold water. The suspension is taken 30 minutes before meals, three times per day, through the swish and swallow technique throughout the radiotherapy period. This group aims to evaluate the effectiveness of the combined treatment in managing radiation-induced mucositis.
- interventionNames
- Dietary Supplement: Arginine and Glutamine Oral Suspension
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- This group includes twenty patients receiving an oral suspension of 5 grams of glutamine dissolved in cold water. The suspension is taken 30 minutes before meals, three times per day, through the swish and swallow technique throughout the radiotherapy period. This group serves as a control to compare the efficacy of glutamine alone with the combined treatment in managing radiation-induced mucositis. General measures and analgesic drugs according to the WHO scale are also provided.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Confirmed histologic diagnosis of H\&N malignancy. Undergoing non-palliative radiotherapy in the oral cavity. Receiving radiation therapy with IMRT or 3D techniques. Received 50-70 Gy of total radiation at 2 Gy/fraction daily, 5 fractions/week. Concurrent chemotherapy with radiotherapy. Presence of Oral Mucositis. Age 20-70 years. Willingness to participate and complete study assessments. V. Exclusion Criteria: Confirmed or medically treated diabetes mellitus. Radiotherapy within the last 6 months. Vulnerable patients.
References
Publications (1)
- DERIVEDHassanein FEA, Mikhail C, Elkot S, Abou-Bakr A. L-arginine vs. L-glutamine oral suspensions for radiation-induced oral mucositis: a triple-blind randomized trial. J Cancer Res Clin Oncol. 2025 Jul 3;151(7):198. doi: 10.1007/s00432-025-06213-x. PMID 40603739