NCT06879366

Evaluation of the Efficacy of Aloe-Vera el Versus Bezydamine Hydrochloride in the Prevention of Radiation Induced Oral Mucositis A Randamized Controlled Clinical Trial

Evaluation of the Efficacy of Aloe-Vera el Versus Bezydamine Hydrochloride in the Treatment of Radiation Induced Oral Mucositis A Randamized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: October 6 University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Background and Rationale Oral mucositis (OM) is one of the most debilitating toxic side effects of radiotherapy and chemotherapy. \]Radiation-induced OM occurs due to the generation of free radicals, which induce mitochondrial dysfunction resulting in increased oxidative stress, DNA damage and cell apoptosis. Epidermal growth factor (EGF) levels were decreased in patients with severe OM, and patients with lower levels of EGF prior to therapy may indicate increased risk of mucosal damage during RT Objectives: The purpose of this study is for Evaluation of the efficacy of aloe-vera gel versus standard treatment as a new option in the treatment of radiation-induced oral mucositis Study population \& Sample size : 40 patient proven to have Head and neck cancer , requiring radiotherapy. Study Design: RCT. The patients are randomized and divided into 2 groups , group A will use alovera gel , Group B will use benzylamide gel, EGF will be measured in saliva before and after 4 weeks treatment Methods Patient's visits will be at baseline, 2 weeks and 4 weeks. At follow up visits patients will be instructed to bring back the consumed container to check that they had totally consumed their previous supply before giving them the new one. Saliva collection to measure EGF by ELIZA

Conditions

• Head and Neck Cancer Patients Treated With Radiotherapy

Interventions

Type	Name	Description
DRUG	Aloe vera gel	10% aloe-vera gel will be prepared under well-controlled laboratory checks
DRUG	Benzydamine Hydrochloride 0.15% Oral gel	Benzydamine Hydrochloride 0.15% Oral gel

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2025-03-17
• Last updated: 2025-03-17

Locations

1 site across 1 country: Egypt