Head and Neck Cancer Patients Treated With RadiotherapyPhase 4NCT06879366
Evaluation of the Efficacy of Aloe-Vera el Versus Bezydamine Hydrochloride in the Prevention of Radiation Induced Oral Mucositis A Randamized Controlled Clinical Trial
A Phase 4 study testing Aloe vera gel and Benzydamine Hydrochloride 0.15% Oral gel in people with Head and Neck Cancer Patients Treated With Radiotherapy, run by October 6 University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Head and Neck Cancer Patients Treated With Radiotherapy
- What is being tested?
- Aloe vera gel and Benzydamine Hydrochloride 0.15% Oral gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Mar 2025
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Aloe-Vera el Versus Bezydamine Hydrochloride in the Treatment of Radiation Induced Oral Mucositis A Randamized Controlled Clinical Trial
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:
Read more
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
- Being tested
- Aloe vera gel, Benzydamine Hydrochloride 0.15% Oral gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aloe vera gelDrug
10% aloe-vera gel will be prepared under well-controlled laboratory checks
Benzydamine Hydrochloride 0.15% Oral gelDrug
Benzydamine Hydrochloride 0.15% Oral gel
| Study group | Role | What they receive |
|---|---|---|
| intervention group: Aloe vera gel | Active comparator | Not described Receives: Drug: Aloe vera gel |
| control group: enzydamine gel | Active comparator | Not described Receives: Drug: Benzydamine Hydrochloride 0.15% Oral gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Mucositis score
- 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.
Measured: 0, 2 weeks , weeks, 6 weeks and 10 weeks
pain score
- 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.
Measured: 0, 2,4,6, and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Jun 2023
- Primary completion1 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer Patients Treated With RadiotherapyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Abdelwhab, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879366
- Sponsor's protocol ID
- N-205-2023
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Aloe-Vera el Versus Bezydamine Hydrochloride in the Treatment of Radiation Induced Oral Mucositis A Randamized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06879366
- Acronym / sponsor ID
- N-205-2023
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 17 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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group: Aloe vera gel | Active comparator | Drug: Aloe vera gel |
| control group: enzydamine gel | Active comparator | Drug: Benzydamine Hydrochloride 0.15% Oral gel |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
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 gel10% aloe-vera gel will be prepared under well-controlled laboratory checks | Drug | intervention group: Aloe vera gel |
| Benzydamine Hydrochloride 0.15% Oral gelBenzydamine Hydrochloride 0.15% Oral gel | Drug | control group: enzydamine gel |
Primary outcome
1) Mucositis score
Time frame: 0, 2 weeks , weeks, 6 weeks and 10 weeks
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.
pain score
Time frame: 0, 2,4,6, and 10 weeks
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.
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 17 Mar 2025.
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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 4 study testing Aloe vera gel and Benzydamine Hydrochloride 0.15% Oral gel in people with Head and Neck Cancer Patients Treated With Radiotherapy, run by October 6 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 1 inclusion and 1 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 17 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
1) Mucositis score (time frame: 0, 2 weeks , weeks, 6 weeks and 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2025.