Comparison Between the Effect of Aloe Vera and Benzydamine Hydrochloride Mouth Gel on Prevention of Pain and Progression of Radiation-induced Oral Mucositis

NCT06862817 | Completed Phase 1

• 1 other identifier: Aloevera & benzydmin on RIOM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Oral mucositis, a painful inflammation and ulceration of the mucous membranes in the mouth, is commonly seen in patients undergoing chemotherapy or radiation therapy. Effective management of this condition is crucial to reduce pain, promote healing, and maintain oral function. Benzydamine mouth gel is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties, making it useful in treating oral mucositis. It works by blocking pain and reducing inflammation, helping to relieve symptoms like soreness and swelling. Studies suggest that benzydamine gel can decrease the severity of mucositis, ease discomfort, and improve patients' quality of life. Aloe vera gel is well-known for its soothing, anti-inflammatory, and wound-healing properties. When applied to oral mucositis lesions, it promotes healing by providing hydration and forming a protective barrier over the affected tissue. Aloe vera's natural compounds, such as glycoproteins and polysaccharides, help in pain relief and accelerate tissue repair, making it a complementary option to reduce mucositis severity. Together, benzydamine and aloe vera gels can be effective in managing oral mucositis. Benzydamine offers immediate pain relief and reduces inflammation, while aloe vera aids in longer-term healing and tissue regeneration. This combination approach has shown promise in enhancing comfort and accelerating recovery for patients with mucositis.

Conditions

Radiation Indused Oral Mucositis

Keywords

RIOM; aloevera; benzydamine; bioadhesive; mucositis

Outcome Measures

Primary Outcomes (1)

• to compere the effect of Aloe vera mouth gel versus benzydamine mouth gel In the Management of pain and progression of Toxicity grading of oral mucositis according to World Health Organization (WHO) and National Cancer Institute Common Toxicity Criteria

  A complete oral examination will be performed within 24 hours of the first dose of study medication and at each visit. Oral areas at risk will be scored for the major signs of oral mucositis (i.e., erythema, pseudomembrane, and ulceration) -Grade 0: no sighns or symptoms * Grade 1(mild) Oral soreness, erythema of mucosa. * Grade 2 (moderate)Oral erythema, ulcers, Patchy pseudomembranous reaction (patches generally ≤1.5 cm in diameter and non-contiguous),but can eat or swallow. * Grade 3 (severe):Confluent pseudomembranous reaction (contiguous patches generally \>1.5 cm in diameter) requiring intravenous hydration. * Grade 4(life threatening): Necrosis or deep ulceration; may include bleeding not induced by minor trauma or abrasion.

  from begining of radiation theraby at baseline and for 6 week ,once every one week

Study Arms (3)

benzydamine hydrochloride mouth gel

ACTIVE COMPARATOR

found that benzydamine mouth rinses and gels could prevent or reduce the severity of oral mucositis.

Drug: Benzydamine Hydrochloride 0.15% Oral gel

aloe vera gel

ACTIVE COMPARATOR

Drug: Aloe vera gel

bioadhesive gel

PLACEBO COMPARATOR

. They incorporate biodegradable mucoadhesive polymers to enhance retention on active mucosal surfaces and regulate the release of the drug

Drug: Aloe vera gel; Drug: bioadhesive gel

Interventions

Aloe vera gel DRUG

Aloe vera mouthgel not only as a potent agent for prevention mucositis, but also as a prevention of candidiasis in patients undergoing radiotherapy of head and neck with its antifungal and immunomodulation properties

aloe vera gel; bioadhesive gel

Benzydamine Hydrochloride 0.15% Oral gel DRUG

. Benzydamine's mechanisms of action are rooted in its anti-inflammatory, anesthetic, and analgesic properties. It has been shown to reduce the synthesis of TNF-α, IL-1β and prostaglandins while also acting as an antioxidant by scavenging reactive oxygen species (ROS) benzydamine inhibits leukocyte-endothelial interactions, thereby decreasing neutrophil degranulation, and helps mitigate histamine-induced vasodilation and vascular permeability.

benzydamine hydrochloride mouth gel

bioadhesive gel DRUG

bioadhesive These polymers increase viscosity through a liquid-to-semi-solid phase transition, improving retention at the administration site and providing a sustained release profile ,Mucoadhesive Dosage Forms These dosage forms are typically employed to administer medications to epithelial surfaces, including the buccal cavity, sublingual area, oral cavity, eyes, nasal passages, vagina, and lungs

bioadhesive gel

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients diagnosed by head and neck cancer indicated for radiotheraby treatment
• Adult age range from 20-55 male and female patients.
• The patients had receiving a total external-beam RT dose of at least 50 Gy in standard fractions where the oral cavity had been exposed to RT.
• The Karnovsky performance status was more than 70%.
• \- Must be able to diffuse gel on oral cavity

You may not qualify if:

• Food allergy.
• Hypersensitivity to benzydamine or typical nonsteroidal anti-inflammatory drugs (NSAIDs).
• Patients who had an existing lesion in the oral cavity (e.g. active infection or ulcer) before staring RT, or those who were unwilling to participate.
• immunedifictincy desease

Sponsors & Collaborators

• Minia University: lead
• Faculty of Medicine, Minia University: collaborator

Study Sites (1)

Arwa Abdelrady

Minya, Minya Governorate, 61111, Egypt

Location

Related Publications (1)

• Daugelaite G, Uzkuraityte K, Jagelaviciene E, Filipauskas A. Prevention and Treatment of Chemotherapy and Radiotherapy Induced Oral Mucositis. Medicina (Kaunas). 2019 Jan 22;55(2):25. doi: 10.3390/medicina55020025.

  PMID: 30678228 BACKGROUND

Related Links

• Benzydamine mechanisms of action reside in its anti-inflammatory, anaesthetic and analgesic nature. It has been demonstrated that it may act both by decreasing TNF-α, IL-1β and prostaglandin synthesis and as an antioxidant (ROS scavenger).

MeSH Terms

Conditions

Mucositis

Interventions

Aloe vera gel; Benzydamine; Gels

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

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 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Model Details: The patients divided into three groups, randomly selected for treatment: Group A: 1. Aloe vera mouth gel will be applied to areas affected by oral mucositis. Group B: benzydamine hydrochloride mouth gel will be applied to areas affected by oral mucositis. Group C: placebo mouth gel will be applied to areas affected by oral mucositis Treatment was given written instructions to apply with 2 mg of the gel and not eat or drink for the subsequent 30 min, 3 times a day from the last second week of RT for the 7 th week.

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: March 6, 2025
• Study Start: November 1, 2023
• Primary Completion: April 11, 2024
• Study Completion: June 15, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)