NCT07020754CompletedPhase 2
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 · Last updated 30 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 6 Jun 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Ain Shams University
- Diseases
- Head and neck cancer
- NCT number
- NCT07020754
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 84
- From 1 Apr 2025 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Who the study is looking for
- 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
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Dentistry, Future University in Egypt Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.