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

Phase 4

Completed

• Conditions: Head and Neck Cancer Patients Treated With Radiotherapy
• Interventions: Drug: Aloe vera gel; Drug: Benzydamine Hydrochloride 0.15% Oral gel

• Registration Number: NCT06879366
• Lead Sponsor: October 6 University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2024-12-01
• Status Verified: 2025-03
• Study Completion: 2025-03-01
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• The study will include patients who are diagnosed with radiation-induced oral mucositis with any of its grades as scored by the world health organization (WHO) oral mucositis grading scale.

Exclusion Criteria

• patients under the age of 18 ,patients receiving any previous treatment for oral mucositis during the last 2 weeks, allergy to aloe-vera, patients with chronic liver disease, infectious diseases (HIV, HBV,HCV,....), immune system dysfunction, haematological diseases and pregnancy or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group: Aloe vera gel	Aloe vera gel	-
control group: enzydamine gel	Benzydamine Hydrochloride 0.15% Oral gel	-

Primary Outcome Measures

Name	Time	Method
1) Mucositis score	0, 2 weeks , weeks, 6 weeks and 10 weeks	1) Mucositis score which was recorded and graded as recommended by WHO . The grading criteria are as follows: grade 0 - no changes; grade I - soreness/(+)erythema; grade II - erythema (++), ulcer, can eat food(erythema with ulcers less than 1 cm2); grade III - ulcer(+++), (erythema with ulcers more than 1 cm2), requires liquid food; and grade IV - ulcer with haemorrhage and necrosis, alimentation not possible.
pain score	0, 2,4,6, and 10 weeks	2) Pain was recorded recommended by the Lindquist/Hickey scale 0 (none)- no pain; 1 (mild) - slight burning; 2 (moderate) - oral pain but able to eat; and 3 (severe) - severe pain and unable to eat.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt