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

NCT06879366 | Completed Phase 4 DMC

• 1 other identifier: N-205-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 1) Mucositis score

  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.

  0, 2 weeks , weeks, 6 weeks and 10 weeks

• pain score

  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.

  0, 2,4,6, and 10 weeks

Study Arms (2)

intervention group: Aloe vera gel

ACTIVE COMPARATOR

Drug: Aloe vera gel

control group: enzydamine gel

ACTIVE COMPARATOR

Drug: Benzydamine Hydrochloride 0.15% Oral gel

Interventions

Aloe vera gel DRUG

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

intervention group: Aloe vera gel

Benzydamine Hydrochloride 0.15% Oral gel DRUG

Benzydamine Hydrochloride 0.15% Oral gel

control group: enzydamine gel

Eligibility Criteria

• Age: 20 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Aloe vera gel; Benzydamine; Gels

Intervention Hierarchy (Ancestors)

Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of oral medicine, diagnosis and periodontology

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: June 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

EG (1)