Oral Mucositis Due to ChemotherapyPhase 2NCT07073092
Propolis for Management of Chemotherapy-Induced Oral Mucositis in Pediatric Patients
A Phase 2 study testing propolis and chlorohexidine mouthwash and topical antifungal in people with Oral Mucositis Due to Chemotherapy, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of propolis in the prevention of oral mucositis and reducing pain score in children undergoing chemotherapy, and assessing its impact on body mass index, pediatric quality of life and total antioxidant assay. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Mucositis Due to Chemotherapy
- What is being tested?
- propolis and chlorohexidine mouthwash and topical antifungal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2025to 30 Jan 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children of both genders less than 18 years receiving intensive chemotherapy.
- Oncology patients receiving intensified chemotherapy at Oncology unit, Children's Hospital, Ain Shams University, Egypt, who meet the following criteria:
- Taking intensified chemotherapy
- A healthy oral mucosa.
Who cannot join
- Allergy to bee products.
- Severe systemic illness unrelated to cancer (Diabetes, Hypertension, …)
- Inability to take oral medication or unwillingness to participate in the study
- Radiotherapy in the head and neck area.
- Malignant or potentially malignant lesions of the oral cavity.
- Undergoing any other procedures to prevent oral mucositis except standard oral care.
- Patients are unable to commit to the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
faculty of dentistry Ain shams university
Cairo
Dina B. Elkhouly, +201063147477, dinaborham@dent.asu.edu.eg
About this study
Official title: Propolis for Management of Chemotherapy-Induced Oral Mucositis in Pediatric Patients: A Randomized Controlled Clinical Trial With Biochemical Analysis
The goal of this clinical trial is to evaluate the efficacy of propolis in the prevention of oral mucositis and reducing pain score in children undergoing chemotherapy, and assessing its impact on body mass index, pediatric quality of life and total antioxidant assay. The main question it aims to answer is:
What is the effect of propolis on oral mucositis scores in children undergoing chemotherapy?
Participants will:
Take propolis 3 times daily for 21 days follow up weekly for 3 weeks
- Conditions
- Oral Mucositis Due to Chemotherapy
- Being tested
- propolis, chlorohexidine mouthwash and topical antifungal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propolisDrug
propolis medicated jelly candy.
chlorohexidine mouthwash and topical antifungalDrug
chlorohexidine mouthwash and topical antifungal
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | propolis medicated jelly candy+ standard oral care (chlorohexidine and topical anti-fungal) three times daily for 21 days Receives: Drug: propolis; Drug: chlorohexidine mouthwash and topical antifungal |
| control group | Active comparator | Standard oral care (chlorohexidine mouth wash and topical anti-fungal) three times daily for 21 days Receives: Drug: chlorohexidine mouthwash and topical antifungal |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral mucositis score (WHO)
Assess the effectiveness of propolis in treatment of chemotherapy induced oral mucositis in pediatric cancer patients using the WHO Scale (WHO), scoring from 0 to 4.
Measured: 3 weeks
Secondary outcomes (4)
pain (VAS)
Assess the effectiveness of propolis on pain levels. Pain will be assessed by (visual analogue scale). The P-VAS evaluation ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "the most severe pain"
Measured: 3 weeks
body mass index
Assess the effectiveness of propolis on BMI in pediatric patients undergoing chemotherapy. Body mass index (BMI, kg/m2) was defined as the body mass (kg) divided by the square of the body height (m).
Measured: 3 weeks
Pediatric Quality of Life
Assess the effectiveness of propolis on Pediatric Quality of Life using the Arabic validated version of Peds QL™ Inventory both Child Self Report and Parent Proxy Report.
0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Often, 4 = Almost Always
Scoring Method:
- Reverse Scoring System: 0 = 100 points, 1 = 75 points, 2 = 50 points, 3 = 25 points, 4 = 0 points 2. Domain Score Calculation: Sum all question scores within a domain and divide by the number of questions in that domain.
- Total PedsQL Score Calculation: Sum all domain scores and divide by the total number of questions. Higher scores indicate better quality of life.
Measured: 3 weeks
Total anti-oxidant assay
Assess the effectiveness of propolis on total antioxidant assay in pediatric patients undergoing chemotherapy using biochemical analysis
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Oral Mucositis Due to ChemotherapyStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Borham Abdelhafez Abdellatif Elkhouly, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073092
- Sponsor's protocol ID
- FDASU-Rec IR/D052520
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Docimo R, Anastasio MD, Bensi C. Chemotherapy-induced oral mucositis in children and adolescents: a systematic review. Eur Arch Paediatr Dent. 2022 Aug;23(4):501-511. doi: 10.1007/s40368-022-00727-5. Epub 2022 Jul 2.
PubMed 35779225Keys A, Fidanza F, Karvonen MJ, Kimura N, Taylor HL. Indices of relative weight and obesity. Int J Epidemiol. 2014 Jun;43(3):655-65. doi: 10.1093/ije/dyu058. Epub 2014 Apr 1.
PubMed 24691951Villa A, Vollemans M, De Moraes A, Sonis S. Concordance of the WHO, RTOG, and CTCAE v4.0 grading scales for the evaluation of oral mucositis associated with chemoradiation therapy for the treatment of oral and oropharyngeal cancers. Support Care Cancer. 2021 Oct;29(10):6061-6068. doi: 10.1007/s00520-021-06177-x. Epub 2021 Mar 31.
PubMed 33788003Gomaa E, Ayoub MM. Vardenafil oral jellies as a potential approach for management of pediatric irritable bowel syndrome. Saudi Pharm J. 2021 Sep;29(9):955-962. doi: 10.1016/j.jsps.2021.07.020. Epub 2021 Jul 27.
PubMed 34588841Dastan F, Ameri A, Dodge S, Hamidi Shishvan H, Pirsalehi A, Abbasinazari M. Efficacy and safety of propolis mouthwash in management of radiotherapy induced oral mucositis; A randomized, double blind clinical trial. Rep Pract Oncol Radiother. 2020 Nov-Dec;25(6):969-973. doi: 10.1016/j.rpor.2020.09.012. Epub 2020 Oct 3.
PubMed 33100913Ibrahim SS, Hassanein FEA, Zaky HW, Gamal H. Clinical and biochemical assessment of the effect of glutamine in management of radiation induced oral mucositis in patients with head and neck cancer: Randomized controlled clinical trial. J Stomatol Oral Maxillofac Surg. 2024 Jun;125(3S):101827. doi: 10.1016/j.jormas.2024.101827. Epub 2024 Mar 15.
PubMed 38493953
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propolis for Management of Chemotherapy-Induced Oral Mucositis in Pediatric Patients: A Randomized Controlled Clinical Trial With Biochemical Analysis
- ClinicalTrials.gov ID
- NCT07073092
- Acronym / sponsor ID
- FDASU-Rec IR/D052520
- Conditions
- Oral Mucositis Due to Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 18 Jul 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.
The goal of this clinical trial is to evaluate the efficacy of propolis in the prevention of oral mucositis and reducing pain score in children undergoing chemotherapy, and assessing its impact on body mass index, pediatric quality of life and total antioxidant assay. The main question it aims to answer is:
What is the effect of propolis on oral mucositis scores in children undergoing chemotherapy?
Participants will:
Take propolis 3 times daily for 21 days follow up weekly for 3 weeks
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: propolis, Drug: chlorohexidine mouthwash and topical antifungalpropolis medicated jelly candy+ standard oral care (chlorohexidine and topical anti-fungal) three times daily for 21 days |
| control group | Active comparator | Drug: chlorohexidine mouthwash and topical antifungalStandard oral care (chlorohexidine mouth wash and topical anti-fungal) three times daily for 21 days |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children of both genders less than 18 years receiving intensive chemotherapy.
- Oncology patients receiving intensified chemotherapy at Oncology unit, Children's Hospital, Ain Shams University, Egypt, who meet the following criteria:
Key exclusion criteria (7 listed)
- Allergy to bee products.
- Severe systemic illness unrelated to cancer (Diabetes, Hypertension, …)
- Inability to take oral medication or unwillingness to participate in the study
- Radiotherapy in the head and neck area.
- Malignant or potentially malignant lesions of the oral cavity.
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 |
|---|---|---|
| propolispropolis medicated jelly candy. | Drug | study group |
| chlorohexidine mouthwash and topical antifungalchlorohexidine mouthwash and topical antifungal | Drug | control group, study group |
Primary outcome
oral mucositis score (WHO)
Time frame: 3 weeks
Assess the effectiveness of propolis in treatment of chemotherapy induced oral mucositis in pediatric cancer patients using the WHO Scale (WHO), scoring from 0 to 4.
4 secondary outcomes
pain (VAS)
Time frame: 3 weeks
body mass index
Time frame: 3 weeks
Pediatric Quality of Life
Time frame: 3 weeks
Total anti-oxidant assay
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Background: PubMed 35779225Docimo R, Anastasio MD, Bensi C. Chemotherapy-induced oral mucositis in children and adolescents: a systematic review. Eur Arch Paediatr Dent. 2022 Aug;23(4):501-511. doi: 10.1007/s40368-022-00727-5. Epub 2022 Jul 2.
- Background: PubMed 24691951Keys A, Fidanza F, Karvonen MJ, Kimura N, Taylor HL. Indices of relative weight and obesity. Int J Epidemiol. 2014 Jun;43(3):655-65. doi: 10.1093/ije/dyu058. Epub 2014 Apr 1.
- Background: PubMed 33788003Villa A, Vollemans M, De Moraes A, Sonis S. Concordance of the WHO, RTOG, and CTCAE v4.0 grading scales for the evaluation of oral mucositis associated with chemoradiation therapy for the treatment of oral and oropharyngeal cancers. Support Care Cancer. 2021 Oct;29(10):6061-6068. doi: 10.1007/s00520-021-06177-x. Epub 2021 Mar 31.
- Background: PubMed 34588841Gomaa E, Ayoub MM. Vardenafil oral jellies as a potential approach for management of pediatric irritable bowel syndrome. Saudi Pharm J. 2021 Sep;29(9):955-962. doi: 10.1016/j.jsps.2021.07.020. Epub 2021 Jul 27.
- Background: PubMed 33100913Dastan F, Ameri A, Dodge S, Hamidi Shishvan H, Pirsalehi A, Abbasinazari M. Efficacy and safety of propolis mouthwash in management of radiotherapy induced oral mucositis; A randomized, double blind clinical trial. Rep Pract Oncol Radiother. 2020 Nov-Dec;25(6):969-973. doi: 10.1016/j.rpor.2020.09.012. Epub 2020 Oct 3.
- Background: PubMed 38493953Ibrahim SS, Hassanein FEA, Zaky HW, Gamal H. Clinical and biochemical assessment of the effect of glutamine in management of radiation induced oral mucositis in patients with head and neck cancer: Randomized controlled clinical trial. J Stomatol Oral Maxillofac Surg. 2024 Jun;125(3S):101827. doi: 10.1016/j.jormas.2024.101827. Epub 2024 Mar 15.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing propolis and chlorohexidine mouthwash and topical antifungal in people with Oral Mucositis Due to Chemotherapy, 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 18 Jul 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina B. Elkhouly (+201063147477, dinaborham@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral mucositis score (WHO) (time frame: 3 weeks). 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 NCT07073092, which also lists 6 linked publications.
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 18 Jul 2025.