Oral MucositisNCT06757270
Efficacy of Aleo Vera Use in Prevention and Treatment of Chemotherapy-Induced Oral Mucositis in a Group of Egyptian Children with Acute Leukemia
A study testing Second arm: Using aleovera for Prevention and Treatment of Chemotherapy-Induced Oral Mucositis in people with Oral Mucositis, run by Ain Shams University at 1 site in Egypt.
Trial summary
evaluatation the efficacy of Aleovera in prevention and treatment of chemotherapy-induced oral mucositis in children suffering from acute leukemia in terms of appearance and severity Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Second arm: Using aleovera for Prevention and Treatment of Chemotherapy-Induced Oral Mucositis
- 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
- 7 Mar 2023to 7 Mar 2024
- Phase
- Interventional
- 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 3 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients suffering from Acute leukemia( Acute Lymphocytic Leukemia ).
- Patients scheduled for chemotherapy treatment.
- Patients who range from 3 to 13 years old.
- Patients with no history of any chemotherapy or radiotherapy. 5 -Both sexes Exclusion Criteria
- 1-Patients scheduled for radiotherapy treatment . 2-Existence of any signs or symptoms of oral mucositis. 3-Unwilling to participation in the study 4- Patients with any other systemic diseases or other neoplasms.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
evaluatation the efficacy of Aleovera in prevention and treatment of chemotherapy-induced oral mucositis in children suffering from acute leukemia in terms of appearance and severity
- Conditions
- Oral Mucositis
- Being tested
- Second arm: Using aleovera for Prevention and Treatment of Chemotherapy-Induced Oral Mucositis
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second arm: Using aleovera for Prevention and Treatment of Chemotherapy-Induced Oral MucositisOther
Second arm : aleovera 3 times daily after brushing teeth
| Study group | Role | What they receive |
|---|---|---|
| Alovera experminted arm | Experimental | Not described Receives: Other: Second arm: Using aleovera for Prevention and Treatment of Chemotherapy-Induced Oral Mucositis |
| second group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of oral mucositis
Assessment the efficacy of aleo vera gel on prevention of chemotherapy-induced oral mucositis through application the gel 3 times daily then patients were assessed daily in terms of appearance and severity of oral mucositis according WHO grading system.
The World Health Organization (WHO) mucositis scale is used to grade the severity of oral mucositis.
Grade 0: No mucositis Grade 1: Soreness/erythema only. Grade 2: Erythema, and ulcers. Able to tolerate solids. Grade 3: Unable to tolerate solids but able to tolerate liquids. Grade 4: Unable to tolerate solids or liquids. Oral alimentation is not possible.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start7 Mar 2023
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757270
- Sponsor's protocol ID
- FDASU-EecIM 022203
- Status last verified
- Mar 2024
- First submitted
- 17 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: after analysis of my results, if be with value i will share
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Aleo Vera Use in Prevention and Treatment of Chemotherapy-Induced Oral Mucositis in a Group of Egyptian Children with Acute Leukemia
- ClinicalTrials.gov ID
- NCT06757270
- Acronym / sponsor ID
- FDASU-EecIM 022203
- Conditions
- Oral Mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 3 Jan 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.
evaluatation the efficacy of Aleovera in prevention and treatment of chemotherapy-induced oral mucositis in children suffering from acute leukemia in terms of appearance and severity
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alovera experminted arm | Experimental | Other: Second arm: Using aleovera for Prevention and Treatment of Chemotherapy-Induced Oral Mucositis |
| second group | No intervention | – |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients suffering from Acute leukemia( Acute Lymphocytic Leukemia ).
- Patients scheduled for chemotherapy treatment.
- Patients who range from 3 to 13 years old.
- Patients with no history of any chemotherapy or radiotherapy. 5 -Both sexes Exclusion Criteria
- 1-Patients scheduled for radiotherapy treatment . 2-Existence of any signs or symptoms of oral mucositis. 3-Unwilling to participation in the study 4- Patients with any other systemic diseases or other neoplasms.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Second arm: Using aleovera for Prevention and Treatment of Chemotherapy-Induced Oral MucositisSecond arm : aleovera 3 times daily after brushing teeth | Other | Alovera experminted arm |
Primary outcome
Prevention of oral mucositis
Time frame: 2 months
Assessment the efficacy of aleo vera gel on prevention of chemotherapy-induced oral mucositis through application the gel 3 times daily then patients were assessed daily in terms of appearance and severity of oral mucositis according WHO grading system. The World Health Organization (WHO) mucositis scale is used to grade the severity of oral mucositis. Grade 0: No mucositis Grade 1: Soreness/erythema only. Grade 2: Erythema, and ulcers. Able to tolerate solids. Grade 3: Unable to tolerate solids but able to tolerate liquids. Grade 4: Unable to tolerate solids or liquids. Oral alimentation is not possible.
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 3 Jan 2025.
- Individual participant dataSharing planned: Undecided. after analysis of my results, if be with value i will share
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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 study testing Second arm: Using aleovera for Prevention and Treatment of Chemotherapy-Induced Oral Mucositis in people with Oral Mucositis, run by Ain Shams 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 0 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 3 Jan 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.
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?
Prevention of oral mucositis (time frame: 2 months). 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 3 Jan 2025.