Radiation Indused Oral MucositisPhase 1/2NCT06862817
Comparison Between the Effect of Aloe Vera and Benzydamine Hydrochloride Mouth Gel on Prevention of Pain and Progression of Radiation-induced Oral Mucositis
A Phase 1/2 study testing Aloe vera gel, Benzydamine Hydrochloride 0.15% Oral gel and bioadhesive gel in people with Radiation Indused Oral Mucositis, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Radiation Indused Oral Mucositis
- What is being tested?
- Aloe vera gel, Benzydamine Hydrochloride 0.15% Oral gel and bioadhesive gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 15 Jun 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Effect of Aloe Vera and Benzydamine Hydrochloride Mouth Gel on Radiation-induced Oral Mucositis (Randomized Clinical Trial)
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.
Read more
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.
Read the 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 .
- Conditions
- Radiation Indused Oral Mucositis
- Being tested
- Aloe vera gel, Benzydamine Hydrochloride 0.15% Oral gel, bioadhesive gel
- Keywords
- RIOM, aloevera, benzydamine, bioadhesive, mucositis
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aloe vera gelDrug
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
Benzydamine Hydrochloride 0.15% Oral gelDrug
. 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.
bioadhesive gelDrug
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
| Study group | Role | What they receive |
|---|---|---|
| benzydamine hydrochloride mouth gel | Active comparator | found that benzydamine mouth rinses and gels could prevent or reduce the severity of oral mucositis. Receives: Drug: Benzydamine Hydrochloride 0.15% Oral gel |
| aloe vera gel | Active comparator | Not described Receives: 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 Receives: Drug: Aloe vera gel; Drug: bioadhesive gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from begining of radiation theraby at baseline and for 6 week ,once every one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Nov 2023
- Primary completion11 Apr 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation Indused Oral MucositisStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arwa Abdelrady Osman, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862817
- Sponsor's protocol ID
- Aloevera & benzydmin on RIOM
- Status last verified
- Mar 2025
- First submitted
- 16 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30678228
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Aloe Vera and Benzydamine Hydrochloride Mouth Gel on Radiation-induced Oral Mucositis (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06862817
- Acronym / sponsor ID
- Aloevera & benzydmin on RIOM
- Conditions
- Radiation Indused Oral Mucositis
- Keywords
- RIOM, aloevera, benzydamine, bioadhesive, mucositis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| benzydamine hydrochloride mouth gel | Active comparator | Drug: Benzydamine Hydrochloride 0.15% Oral gelfound that benzydamine mouth rinses and gels could prevent or reduce the severity of oral mucositis. |
| aloe vera gel | Active comparator | Drug: Aloe vera gel |
| bioadhesive gel | Placebo comparator | Drug: Aloe vera gel, Drug: bioadhesive gel. They incorporate biodegradable mucoadhesive polymers to enhance retention on active mucosal surfaces and regulate the release of the drug |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aloe vera gelAloe 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 | Drug | aloe vera gel, bioadhesive gel |
| Benzydamine Hydrochloride 0.15% Oral gel. 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. | Drug | benzydamine hydrochloride mouth gel |
| bioadhesive gelbioadhesive 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 | Drug | bioadhesive gel |
Primary outcome
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
Time frame: from begining of radiation theraby at baseline and for 6 week ,once every one week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Background: PubMed 30678228Daugelaite 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.
- 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).Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aloe vera gel, Benzydamine Hydrochloride 0.15% Oral gel and bioadhesive gel in people with Radiation Indused Oral Mucositis, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: from begining of radiation theraby at baseline and for 6 week ,once every one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06862817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.