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

Summary

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

• Radiation Mucositis
• Head and Neck Cancer

Interventions

DIETARY_SUPPLEMENT

Glutamine Oral Suspension

Participants in this group will receive an oral suspension containing 5 grams of glutamine dissolved in cold water. This solution is administered 30 minutes before meals, three times per day, using the swish and swallow technique throughout the radiotherapy period. This control intervention serves to compare the effects of glutamine alone with the combined arginine and glutamine treatment. In addition to the glutamine suspension, patients in this group will receive general measures and analgesic drugs according to the WHO scale to manage symptoms of mucositis.

DIETARY_SUPPLEMENT

Arginine and Glutamine Oral Suspension

Participants in this group will receive an oral suspension containing 5 grams of arginine and 5 grams of glutamine dissolved in cold water. This solution is administered 30 minutes before meals, three times per day, using the swish and swallow technique throughout the radiotherapy period. The swish and swallow technique involves patients swishing the solution around the oral mucosa to ensure even distribution before swallowing. This intervention aims to evaluate the combined effect of arginine and glutamine on reducing the severity of radiation-induced mucositis, improving mucosal healing, and providing symptomatic relief.

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-20

Primary Completion

2024-06-20

Completion

2024-09-20

Countries

• Egypt

Study Locations