Clinical trial NCT06862817: Comparison Between the Effect of Aloe Vera and Benzydamine Hydrochloride Mouth Gel on Prevention of Pain and Progression of Radiation-induced Oral Mucositis
Official title: Comparison Between the Effect of Aloe Vera and Benzydamine Hydrochloride Mouth Gel on Radiation-induced Oral Mucositis (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Radiation Indused Oral Mucositis
Keywords: RIOM
aloevera
benzydamine
bioadhesive
mucositis
Lead sponsor: Minia University
Sponsor class: OTHER
Collaborators: name: Faculty of Medicine, Minia University
First posted: 2025-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Head and neck cancer (HNC) is a broad term, including epithelial malignancies that occur in the paranasal sinuses, nasal cavity, oral cavity, pharynx, and larynx. Almost all these malignancies are head and neck squamous cell carcinoma (HNSCC).

HNSCC is the sixth most common cancer worldwide, with 890,000 new cases and 450,000 deaths in 2018. The principal modalities of curative therapy for locally or locoregionally confined HNSCC are resection, radiation and systemic therapy. Treatment planning should aim for the most highly curative approach, while optimizing preservation of function

Head and neck cancers (HNC) are often treated with radiation therapy (RT), a technique that utilizes ionizing radiation and exerts therapeutic effect by semi-selectively damaging the genetic material of vulnerable malignant cells, either directly or through the production of free radicals, resulting in cell death.

Radiation-induced oral mucositis (RIOM) is one of the major ionizing radiation toxicities and normal tissue injuries that result from radiotherapy. RIOM is a normal tissue injury lasting between 7 and 98 days, which starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure.

Oral mucositis is defined as inflammation of oral mucosa resulting from cancer therapy typically manifesting as atrophy, swelling, erythema and ulceration. The condition may be exacerbated by local factors, such as trauma from teeth, or microbial colonization. The term stomatitis refers to any inflammatory condition of oral tissue, including mucosa, dentition/periapices, and periodontium. Stomatitis thus defines a broader range of pathoses of oral tissues, including mucositis.

Treatment interruption may be required in patients who develop severe OM as further radiotherapy may lead to permanent loss of the stem cells and morbidity to treatment. But it should be noted that interruption of treatment is at the cost of reduced local control and may be compromised survival. Hence, it is important to have a balance of these factors when thinking of interrupting the treatment. It is also important that treatment is restarted at the earliest so that there is minimum gap in the treatment.

Currently, there is no definite efficient therapy for mucositis or its pain Multiple studies have been performed to propose preventive and therapeutic management. implementing proper oral hygiene measure ,removal of local irritants, and frequent rinsing with combination therapies are the current main supportive measure to mollify the severity of oral mucositis and reduce its attributed risk.

Numerous adjunctive treatments for the prevention of chemotherapy and radiotherapy -induced mucositis are now being studied such as the administration of honey, zinc, selenium, topical vitamin E, and glutamine .

Lalla RV recommend the use of benzydamine oral rinse for prevention of radiation induced OM in HNC patients treated with moderate doses of radiation therapy.

Aloe vera (named Aloe barbadensis in Latin), contains polysaccharides, anthraquinone, lectin, superoxide dismutase (an antioxidant enzyme), glycoprotein, amino acids, vitamins C and E and minerals. revealed the anti inflammatory, analgesic, liver protection, antiproliferative, anticarcinogenic and antiaging properties .

Eligibility criteria: Inclusion Criteria:

1. patients diagnosed by head and neck cancer indicated for radiotheraby treatment
2. Adult age range from 20-55 male and female patients.
3. 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.
4. The Karnovsky performance status was more than 70%.
5. - Must be able to diffuse gel on oral cavity

Exclusion Criteria:

1. Food allergy.
2. Hypersensitivity to benzydamine or typical nonsteroidal anti-inflammatory drugs (NSAIDs).
3. 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.
4. immunedifictincy desease

Primary outcomes:
measure: 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
timeFrame: from begining of radiation theraby at baseline and for 6 week ,once every one week
Secondary outcomes:
Other outcomes:
Locations:
city: Minia
country: Egypt
facility: Arwa Abdelrady
Study officials:
References:
citation: 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.