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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

NCT07020754 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-01-30

No results posted yet for this study

Summary

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

  • Radiation Induced Oral Mucositis
  • Oral Mucositis
  • Oral Mucositis Due to Radiation

Interventions

DIETARY_SUPPLEMENT

L-arginine Oral Suspension

Type: Dietary supplement Dosage: 5 g L-arginine + 5 g maltodextrin Route: Oral (swish-and-swallow) Frequency: Three times daily, 30 minutes before meals Duration: From the 2nd to the 7th week of radiotherapy

DIETARY_SUPPLEMENT

L-glutamine Oral Suspension

Type: Dietary supplement Dosage: 5 g L-glutamine + 5 g maltodextrin Route: Oral (swish-and-swallow) Frequency: Three times daily, 30 minutes before meals Duration: From the 2nd to the 7th week of radiotherapy

DIETARY_SUPPLEMENT

Maltodextrin Oral Suspension (Control)

Type: Placebo comparator Dosage: 10 g maltodextrin Route: Oral (swish-and-swallow) Frequency: Three times daily, 30 minutes before meals Duration: From the 2nd to the 7th week of radiotherapy

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-01-01
Completion
2026-01-25

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07020754 on ClinicalTrials.gov