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

NCT ID: NCT06879366

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-03-01

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

Conditions

Head and Neck Cancer Patients Treated With Radiotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

intervention group: Aloe vera gel

Group Type: ACTIVE_COMPARATOR

Aloe vera gel

Intervention Type: DRUG

10% aloe-vera gel will be prepared under well-controlled laboratory checks

control group: enzydamine gel

Group Type: ACTIVE_COMPARATOR

Benzydamine Hydrochloride 0.15% Oral gel

Intervention Type: DRUG

Benzydamine Hydrochloride 0.15% Oral gel

Interventions

Aloe vera gel

10% aloe-vera gel will be prepared under well-controlled laboratory checks

Intervention Type: DRUG

Benzydamine Hydrochloride 0.15% Oral gel

Benzydamine Hydrochloride 0.15% Oral gel

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Amira Abdelwhab

lecturer of oral medicine, diagnosis and periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-205-2023

Identifier Type: -

Identifier Source: org_study_id