Mucositis OralPhase 2/3NCT05214495
Omega-3 Hydrogel and Prevention of Oral Mucositis
A Phase 2/3 study testing topical oral Omega-3 hydrogel and conventional preventive treatment in people with Mucositis Oral, run by Basma Morsy at 1 site in Egypt.
Trial summary
Oral mucositis (OM) is recognized as one of the most frequent debilitating sequela encountered by head and neck cancer (HNC) patients treated by radiotherapy. The objective of the study is to assess primarily the effect of topical oral Omega-3 hydrogel in prevention of radiation-induced oral mucositis and secondarily… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mucositis Oral
- What is being tested?
- topical oral Omega-3 hydrogel and conventional preventive treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Feb 2022to 1 Sep 2022
- Phase
- Phase 2/3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
- Patients whose radiotherapy treatment planned dose is 50 Gy or above
- Males and females with an age not less than 18 years
- Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.
Who cannot join
- Patients under Anticoagulants such as warfarin, heparin, or aspirin.
- Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
- Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Topical Oral Omega-3 Hydrogel in Prevention of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Clinical Trial
Oral mucositis (OM) is recognized as one of the most frequent debilitating sequela encountered by head and neck cancer (HNC) patients treated by radiotherapy. The objective of the study is to assess primarily the effect of topical oral Omega-3 hydrogel in prevention of radiation-induced oral mucositis and secondarily, to test the effect of topical oral Omega-3 hydrogel on oral microbiome.
- Conditions
- Mucositis Oral
- Being tested
- topical oral Omega-3 hydrogel, conventional preventive treatment
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical oral Omega-3 hydrogelDrug
Topical oral Omega-3 hydrogel prepared from fish oil
conventional preventive treatmentDrug
topical treatment including antifungal agents, anti-inflammatory mouthwash, sodium bicarbonate mouthwash.
Topical anesthetics agent, topical analgesic gel as well as systemic analgesics (if needed)
| Study group | Role | What they receive |
|---|---|---|
| Topical oral Omega-3 hydrogel group | Experimental | Patients will be given topical oral Omega-3 hydrogel Receives: Drug: topical oral Omega-3 hydrogel |
| Conventional preventive treatment group | Active comparator | Patients will be given conventional preventive treatment Receives: Drug: conventional preventive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Mucositis Severity
Radiation induced head and neck toxicity will be scored by a scale based on clinical features from Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start9 Feb 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucositis OralStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basma Morsy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Basma Morsy, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214495
- Sponsor's protocol ID
- 0290-09/2021
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Oral Omega-3 Hydrogel in Prevention of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05214495
- Acronym / sponsor ID
- 0290-09/2021
- Conditions
- Mucositis Oral
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Basma MorsyUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 28 Jan 2022 (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 (OM) is recognized as one of the most frequent debilitating sequela encountered by head and neck cancer (HNC) patients treated by radiotherapy. The objective of the study is to assess primarily the effect of topical oral Omega-3 hydrogel in prevention of radiation-induced oral mucositis and secondarily, to test the effect of topical oral Omega-3 hydrogel on oral microbiome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical oral Omega-3 hydrogel group | Experimental | Drug: topical oral Omega-3 hydrogelPatients will be given topical oral Omega-3 hydrogel |
| Conventional preventive treatment group | Active comparator | Drug: conventional preventive treatmentPatients will be given conventional preventive treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
- Patients whose radiotherapy treatment planned dose is 50 Gy or above
- Males and females with an age not less than 18 years
- Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.
Key exclusion criteria (3 listed)
- Patients under Anticoagulants such as warfarin, heparin, or aspirin.
- Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
- Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
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 |
|---|---|---|
| topical oral Omega-3 hydrogelTopical oral Omega-3 hydrogel prepared from fish oil | Drug | Topical oral Omega-3 hydrogel group |
| conventional preventive treatmenttopical treatment including antifungal agents, anti-inflammatory mouthwash, sodium bicarbonate mouthwash. Topical anesthetics agent, topical analgesic gel as well as systemic analgesics (if needed) | Drug | Conventional preventive treatment group |
Primary outcome
Oral Mucositis Severity
Time frame: up to 6 weeks
Radiation induced head and neck toxicity will be scored by a scale based on clinical features from Common Terminology Criteria for Adverse Events (CTCAE) v5.0
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 31 Jan 2023.
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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 2/3 study testing topical oral Omega-3 hydrogel and conventional preventive treatment in people with Mucositis Oral, run by Basma Morsy 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 3 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 31 Jan 2023. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Oral Mucositis Severity (time frame: up to 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 31 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.