Radiation-induced Oral MucositisNCT07813923
Citrus Sinensis Peel Gel for Radiation-Induced Oral Mucositis
A study testing Citrus sinensis peel extract gel and Conventional supportive treatment in people with Radiation-induced Oral Mucositis and Head and Neck Cancer, run by Alexandria University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to evaluate the efficacy of Citrus sinensis peel extract gel in the treatment of radiation-induced oral mucositis in head and neck cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Radiation-induced Oral Mucositis, Head and Neck Cancer
- What is being tested?
- Citrus sinensis peel extract gel and Conventional supportive treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 30 Jun 2027
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing radiotherapy for head and neck cancer as postoperative (adjuvant) therapy or definitive therapy.
- Patients between 18-50 years.
- Both males and females.
- Patients whose radiotherapy treatment planned dose is 50 Gy or above 8
- Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.
- Patients who are clinically diagnosed with oral mucositis (WHO grade ≥1).
Who cannot join
- Smokers, due to impaired mucosal healing and increased inflammation
- Pregnant and lactating women
- Patients with poor oral hygiene
- Use of systemic or topical mucositis treatments within the past 7 days
- Patients allergic to orange
- Patients allergic to citrus peel or gel formulation components
- Patients with systemic diseases (e.g., hypertension, diabetes, cardic diseases etc.)
- Patients who have other oral lesions not related to mucositis (e.g., herpetic ulcers, candidiasis)
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
outpatient clinic of the Department of Clinical Oncology, Faculty of Medicine
Alexandria, Alexandria Governorate, 11553
About this study
Official title: The Effect of Citrus Sinensis Peel Gel on Radiation-induced Oral Mucositis in Head and Neck Cancer Patients (Randomized Controlled Clinical Trial)
This randomized controlled clinical trial aims to evaluate the efficacy of Citrus sinensis peel extract gel in the treatment of radiation-induced oral mucositis in head and neck cancer patients. Thirty adult patients with head and neck cancer who develop oral mucositis during radiotherapy will be randomly allocated into two parallel groups. The intervention group will receive Citrus sinensis peel extract gel, while the control group will receive conventional supportive treatment. Clinical outcomes will be evaluated at baseline, 3 weeks, and 6 weeks, including pain intensity and severity of oral mucositis. Salivary total antioxidant capacity will be assessed at baseline and after 6 weeks.
Read the detailed description
Radiotherapy is an important treatment modality for head and neck cancer, but radiation-induced oral mucositis is a frequent complication that may cause significant pain and interfere with oral function and quality of life.
This randomized controlled, single-blinded clinical trial will evaluate the efficacy of Citrus sinensis peel extract gel in the treatment of radiation-induced oral mucositis in head and neck cancer patients.
A total of 30 eligible patients will be randomly allocated into two parallel groups of 15 participants each. The experimental group will receive Citrus sinensis peel extract gel containing 5% w/w ethanolic Citrus sinensis peel extract. The gel will be applied directly to the affected oral mucosa three times daily, preferably after meals and oral rinsing, for 6 weeks. Participants will be instructed to avoid eating or drinking for 30 minutes after application.
The control group will receive conventional supportive treatment consisting of miconazole oral gel, anti-inflammatory mouthwash, sodium bicarbonate mouthwash, BBC oral spray, Oracure gel, and systemic analgesics as needed.
Clinical evaluation will be performed at baseline, 3 weeks, and 6 weeks. Pain intensity will be assessed using a Visual Analogue Scale (VAS), and oral mucositis severity will be assessed using the World Health Organization (WHO) oral toxicity scale. The Arabic version of the MD Anderson Symptom Inventory-Head and Neck module (MDASI-HN) will also be used to assess symptom burden. Clinical photographs will be obtained at the assessment time points.
Unstimulated saliva will be collected at baseline and 6 weeks to assess total antioxidant capacity using a validated colorimetric assay.
The study will be conducted at the Department of Oral Medicine, Faculty of Dentistry, Alexandria University, with recruitment from the outpatient clinic of the Department of Clinical Oncology, Faculty of Medicine, Alexandria University.
- Being tested
- Citrus sinensis peel extract gel, Conventional supportive treatment
- Keywords
- Citrus sinensis, Oral mucositis, Head and neck cancer, Radiotherapy, Herbal therapy, Radiation, Herbal gel
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrus sinensis peel extract gelDrug
Citrus sinensis peel extract gel containing 5% w/w ethanolic Citrus sinensis peel extract in a gel-forming polymer. The gel will be applied directly to the affected oral mucosa three times daily, preferably after meals and oral rinsing, for 6 weeks. Participants will be instructed to avoid eating or drinking for 30 minutes after application. In case of hypersensitivity, the intervention will be discontinued and the study team will be notified.
Conventional supportive treatmentDrug
Conventional supportive treatment consisting of miconazole oral gel, anti-inflammatory mouthwash, sodium bicarbonate mouthwash, BBC oral spray, Oracure gel, and systemic analgesics as needed.
| Study group | Role | What they receive |
|---|---|---|
| Citrus sinensis Peel Gel | Experimental | 15 Participants will receive Citrus sinensis peel extract gel containing 5% w/w ethanolic Citrus sinensis peel extract. The gel will be applied directly to the affected oral mucosa three times daily, preferably after meals and oral rinsing, for 6 weeks. Participants will be instructed to avoid eating or drinking for 30 minutes after application. Receives: Drug: Citrus sinensis peel extract gel |
| Conventional Treatment | Active comparator | Participants will receive conventional supportive treatment consisting of miconazole oral gel, anti-inflammatory mouthwash, sodium bicarbonate mouthwash, BBC oral spray, Oracure gel, and systemic analgesics as needed. Receives: Drug: Conventional supportive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral mucositis severity
Severity of radiation-induced oral mucositis assessed using the World Health Organization (WHO) oral toxicity scale. World Health Organization Oral Toxicity Scale is ranging from Grade 0 to Grade 4, where Grade 0 indicates no toxicity and Grade 4 represents the most severe toxicity. Higher grades indicate a worse outcome (greater severity of oral mucositis).
Measured: Baseline, 3 weeks, and 6 weeks.
Secondary outcomes (3)
Pain intensity
Pain intensity measured using the Visual Analogue Scale (VAS). Pain intensity will be assessed using the Visual Analogue Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate a worse outcome (greater pain).
Measured: Baseline, 3 weeks, and 6 weeks.
Salivary total antioxidant capacity
Total antioxidant capacity (TAC) measured in unstimulated saliva using a validated colorimetric assay.
Measured: Baseline and 6 weeks.
Clinical photographic assessment
Clinical photographs documenting the appearance and severity of oral mucositis.
Measured: Baseline, 3 weeks, and 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced Oral MucositisStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to one of two parallel groups: a Citrus sinensis peel extract gel group or a conventional supportive treatment group. Participants will receive their assigned intervention for 6 weeks, with clinical assessments performed at baseline, 3 weeks, and 6 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eglal Mohamed Moussa, Professor of Oral medicine, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813923
- Sponsor's protocol ID
- 00010556 - IORG 0008839
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 16 Sep 2026
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Citrus Sinensis Peel Gel on Radiation-induced Oral Mucositis in Head and Neck Cancer Patients (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07813923
- Acronym / sponsor ID
- 00010556 - IORG 0008839
- Keywords
- Citrus sinensis, Oral mucositis, Head and neck cancer, Radiotherapy, Herbal therapy, Radiation, Herbal gel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Sep 2026 (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.
This randomized controlled clinical trial aims to evaluate the efficacy of Citrus sinensis peel extract gel in the treatment of radiation-induced oral mucositis in head and neck cancer patients. Thirty adult patients with head and neck cancer who develop oral mucositis during radiotherapy will be randomly allocated into two parallel groups. The intervention group will receive Citrus sinensis peel extract gel, while the control group will receive conventional supportive treatment. Clinical outcomes will be evaluated at baseline, 3 weeks, and 6 weeks, including pain intensity and severity of oral mucositis. Salivary total antioxidant capacity will be assessed at baseline and after 6 weeks.
Detailed description
Radiotherapy is an important treatment modality for head and neck cancer, but radiation-induced oral mucositis is a frequent complication that may cause significant pain and interfere with oral function and quality of life.
This randomized controlled, single-blinded clinical trial will evaluate the efficacy of Citrus sinensis peel extract gel in the treatment of radiation-induced oral mucositis in head and neck cancer patients.
A total of 30 eligible patients will be randomly allocated into two parallel groups of 15 participants each. The experimental group will receive Citrus sinensis peel extract gel containing 5% w/w ethanolic Citrus sinensis peel extract. The gel will be applied directly to the affected oral mucosa three times daily, preferably after meals and oral rinsing, for 6 weeks. Participants will be instructed to avoid eating or drinking for 30 minutes after application.
The control group will receive conventional supportive treatment consisting of miconazole oral gel, anti-inflammatory mouthwash, sodium bicarbonate mouthwash, BBC oral spray, Oracure gel, and systemic analgesics as needed.
Clinical evaluation will be performed at baseline, 3 weeks, and 6 weeks. Pain intensity will be assessed using a Visual Analogue Scale (VAS), and oral mucositis severity will be assessed using the World Health Organization (WHO) oral toxicity scale. The Arabic version of the MD Anderson Symptom Inventory-Head and Neck module (MDASI-HN) will also be used to assess symptom burden. Clinical photographs will be obtained at the assessment time points.
Unstimulated saliva will be collected at baseline and 6 weeks to assess total antioxidant capacity using a validated colorimetric assay.
The study will be conducted at the Department of Oral Medicine, Faculty of Dentistry, Alexandria University, with recruitment from the outpatient clinic of the Department of Clinical Oncology, Faculty of Medicine, Alexandria University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to one of two parallel groups: a Citrus sinensis peel extract gel group or a conventional supportive treatment group. Participants will receive their assigned intervention for 6 weeks, with clinical assessments performed at baseline, 3 weeks, and 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Citrus sinensis Peel Gel | Experimental | Drug: Citrus sinensis peel extract gel15 Participants will receive Citrus sinensis peel extract gel containing 5% w/w ethanolic Citrus sinensis peel extract. The gel will be applied directly to the affected oral mucosa three times daily, preferably after meals and oral rinsing, for 6 weeks. Participants will be instructed to avoid eating or drinking for 30 minutes after application. |
| Conventional Treatment | Active comparator | Drug: Conventional supportive treatmentParticipants will receive conventional supportive treatment consisting of miconazole oral gel, anti-inflammatory mouthwash, sodium bicarbonate mouthwash, BBC oral spray, Oracure gel, and systemic analgesics as needed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients undergoing radiotherapy for head and neck cancer as postoperative (adjuvant) therapy or definitive therapy.
- Patients between 18-50 years.
- Both males and females.
- Patients whose radiotherapy treatment planned dose is 50 Gy or above 8
- Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.
Key exclusion criteria (8 listed)
- Smokers, due to impaired mucosal healing and increased inflammation
- Pregnant and lactating women
- Patients with poor oral hygiene
- Use of systemic or topical mucositis treatments within the past 7 days
- Patients allergic to orange
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 |
|---|---|---|
| Citrus sinensis peel extract gelCitrus sinensis peel extract gel containing 5% w/w ethanolic Citrus sinensis peel extract in a gel-forming polymer. The gel will be applied directly to the affected oral mucosa three times daily, preferably after meals and oral rinsing, for 6 weeks. Participants will be instructed to avoid eating or drinking for 30 minutes after application. In case of hypersensitivity, the intervention will be discontinued and the study team will be notified. | Drug | Citrus sinensis Peel Gel |
| Conventional supportive treatmentConventional supportive treatment consisting of miconazole oral gel, anti-inflammatory mouthwash, sodium bicarbonate mouthwash, BBC oral spray, Oracure gel, and systemic analgesics as needed. | Drug | Conventional Treatment |
Primary outcome
Oral mucositis severity
Time frame: Baseline, 3 weeks, and 6 weeks.
Severity of radiation-induced oral mucositis assessed using the World Health Organization (WHO) oral toxicity scale. World Health Organization Oral Toxicity Scale is ranging from Grade 0 to Grade 4, where Grade 0 indicates no toxicity and Grade 4 represents the most severe toxicity. Higher grades indicate a worse outcome (greater severity of oral mucositis).
3 secondary outcomes
Pain intensity
Time frame: Baseline, 3 weeks, and 6 weeks.
Salivary total antioxidant capacity
Time frame: Baseline and 6 weeks.
Clinical photographic assessment
Time frame: Baseline, 3 weeks, and 6 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 16 Sep 2026.
Related trials for Radiation-induced Oral Mucositis
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Active, not recruiting
Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
Mucositis Oral, Head and Neck Cancer
Enrolling by invitationPhase 1/2
Photobiomodulation Alone Versus Photobiomodulation Combined With Topical Oral Oxygen Therapy for Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Clinical Trial
Mucositis Oral, Head & Neck Cancer
Active, not recruitingPhase 2/3
Sodium Bicarbonate for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.
Nasopharyngeal Cancinoma (NPC)
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.
Eglal Mohamed Moussa, Professor of Oral medicine principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citrus sinensis peel extract gel and Conventional supportive treatment in people with Radiation-induced Oral Mucositis and Head and Neck Cancer, run by Alexandria 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 6 inclusion and 8 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 16 Sep 2026. 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?
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 Rawan I Assy, Bachelor (+201090914664, Rawan.Asi.dent@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral mucositis severity (time frame: Baseline, 3 weeks, and 6 weeks.). 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 16 Sep 2026.