NCT06764420

Effect of Arginine and Glutamine on Radiation-induced Oral Mucositis: a Trible Blinded Randomized Controlled Clinical Trial

Completed NA Last updated 8 January 2025

What this trial tests

NA trial testing Glutamine Oral Suspension in Radiation Mucositis in 40 participants. Completed in 20 September 2024.

Timeline

20 May 2023

Primary endpoint
20 June 2024

20 September 2024

Quick facts

Lead sponsor	Ain Shams University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	40
Start date	20 May 2023
Primary completion	20 June 2024
Estimated completion	20 September 2024
Sites	1 location across Egypt

Drugs / interventions tested

• Glutamine Oral Suspension
• Arginine and Glutamine Oral Suspension

Conditions studied

• Radiation Mucositis — all drugs for Radiation Mucositis →
• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

Ain Shams University

Who can join

Eligibility, any sex, with Radiation Mucositis or Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. L-arginine vs. L-glutamine oral suspensions for radiation-induced oral mucositis: a triple-blind randomized trial.
   Hassanein FEA, Mikhail C, Elkot S, Abou-Bakr A. · · 2025 · cited 7× · PMID 40603739 · DOI 10.1007/s00432-025-06213-x
2. Radiomitigators: Breakthroughs in Post-Radiation Recovery.
   Obrador E, Estrela JM, López-Blanch R, Moreno-Murciano P, et al · · 2026 · PMID 41897526 · DOI 10.3390/antiox15030381
3. The Effect of Myc Inhibition Combined with the Synergistic Effect of Photothermal, Photodynamic and Radiotherapy in Tumor Treatment.
   Cui Y, Yang W, Liu W, Li Y, et al · · 2025 · PMID 41103361 · DOI 10.2147/ijn.s526592