Radiation MucositisNCT05322421
Effectiveness of Topical Olive Oil in Prevention and Management of Radiation Induced Oral Mucositis
A study testing Topical Olive Oil and Sodium bicarbonate 5% solution in people with Radiation Mucositis and Oral Mucositis (Ulcerative) Due to Radiation, run by Salma Hesham Elhoufi at 1 site in Egypt.
Trial summary
This research aims to investigate the effectiveness of topical olive oil application both clinically and biochemically as a suitable affordable treatment modality for prevention and management of radiation oral mucositis and its associated pain for head and neck cancer patients receiving radiotherapy. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Radiation Mucositis, Oral Mucositis (Ulcerative) Due to Radiation, Radiation-Induced Mucositis
- What is being tested?
- Topical Olive Oil and Sodium bicarbonate 5% solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2022to 15 Dec 2022
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are aged above 25 years up to 65 years.
- Both genders are eligible.
- Patients with head and neck cancer who are planned to receive radiotherapy either as postoperative (adjuvant after surgery) or definitive therapy.
- Patients planned to receive radiotherapy treatment with a dose of 60-70 Gy.
Who cannot join
- Patients with known sensitivity to olive oil and/or any of its products
- Patients with gingival or oral ulceration or mucositis
- Smokers
- Vulnerable patients (pregnant women, neonates, children, prisoners, persons with physical handicaps or mental disabilities)
- Pregnant and lactating women.
- Patients with any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
- Patients suffering from any physical or mental disabilities that would interfere with or be affected by the study procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Topical Olive Oil in Prevention and Management of Radiation Induced Oral Mucositis: a Randomised Clinical Control Trial
This research aims to investigate the effectiveness of topical olive oil application both clinically and biochemically as a suitable affordable treatment modality for prevention and management of radiation oral mucositis and its associated pain for head and neck cancer patients receiving radiotherapy.
Read the detailed description
Twenty adult patients seeking radiotherapy treatment for head and neck cancer are to be selected. Patients meeting the eligibility criteria are to be equally and randomly allocated in 2 different groups. Group 1 will include10 patients receiving topical olive oil application, twice daily (Experimental arm). Group 2 will include 10 patients receiving Sodium bicarbonate 5% solution, twice daily (Control arm). Both intervention and control groups will start the application of the agents two days before the induction of radiotherapy. Evaluation will be done using World Health Organization (WHO) scale for oral mucositis to record the extent and severity of oral mucositis. Pain and discomfort will be evaluated using Numeric Rating Scale (NRS). Clinical evaluation using both scales will be performed after starting radiotherapy every other week ( after 2 weeks, after 4 weeks and after 6 weeks at the end of the treatment). Patients scores will be recorded at similar intervals. Total Antioxidant Capacity "TAC" will be used to study the biochemical effect of topical olive oil application by evaluating the oxidative stress in the saliva. Saliva samples will be collected from all patients of both groups prior to the beginning of radiotherapy, and a second sample will be collected after six weeks.
- Conditions
- Radiation Mucositis, Oral Mucositis (Ulcerative) Due to Radiation, Radiation-Induced Mucositis
- Being tested
- Topical Olive Oil, Sodium bicarbonate 5% solution
- Keywords
- radiation, mucositis, oral, stomatitis, olive oil
- Medical subject headings
- Stomatitis, Ulcer, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Olive OilOther
Olive oil will be placed in 200 ml opaque glass containers. For each application, a new stick with a sponge will be submerged into one of the agents to absorb then coat the tongue, buccal mucosa, lips, and hard palate. Patients will be instructed to refrain form eating for 1 hour after the application
Sodium bicarbonate 5% solutionOther
Sodium bicarbonate 5% solution will be placed in 200 ml opaque glass containers. For each application, a new stick with a sponge will be submerged into one of the agents to absorb then coat the tongue, buccal mucosa, lips, and hard palate. Patients will be instructed to refrain form eating for 1 hour after the application
| Study group | Role | What they receive |
|---|---|---|
| Olive Oil | Experimental | Will include10 patients receiving topical olive oil application, twice daily Receives: Other: Topical Olive Oil |
| Sodium Bicarbonate | Active comparator | Will include 10 patients receiving Sodium bicarbonate 5% solution, twice daily Receives: Other: Sodium bicarbonate 5% solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Oral Radiation mucositis
Number of participants who develop Radiation mucositis according to the WHO Scale. (grade 0 indicates that no changes have occurred in the oral cavity and grade 4 indicates the worst level of mucositis )
Measured: Every other week ( 2 weeks, 4 weeks and 6 at the end of the treatment)
Grade of oral radiation mucositis
Clinical evaluation using the WHO scale will be performed to record the changes in the oral cavity after starting radiotherapy, (grade 0 indicates that no changes have occurred in the oral cavity and grade 4 indicates the worst level of mucositis )
Measured: Every other week ( 2 weeks, 4 weeks and 6 weeks at the end of the treatment)
Secondary outcomes (2)
Post operative pain assessment using Numeric Pain Rating Scale
To evaluate patient's perception of postoperative pain during the treatment time using the NRS (Numeric Pain Rating Scale). The NRS is an 11-point numeric scale that ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: Patients scores will be recorded after starting radiotherapy every other week ( 2 weeks, 4 weeks and 6 weeks at the end of the treatment)
Total antioxidant capacity
To evaluate the biochemical effect of topical olive oil application using the Total Antioxidant Capacity (TAC) test in the saliva of patients with radiation oral mucositis
Measured: Salivary samples will be collected at baseline before the induction of radiotherapy and at 6 weeks at the end of the treatment for TAC analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start10 Jan 2022
- Primary completion10 Sep 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation MucositisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a parallel randomized control clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salma Hesham Elhoufi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salma Hesham Elhoufi, Ain Shams University
- Investigators
- Suzan S Ibrahim, Professor, Study director, Ain Shams UniversityRadwa Ragheb, Lecturer, Study director, Ain Shams UniversitySalma H Elhoufi, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322421
- Sponsor's protocol ID
- FDASU-REC 964123
- Status last verified
- Aug 2024
- First submitted
- 1 Nov 2021
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Topical Olive Oil in Prevention and Management of Radiation Induced Oral Mucositis: a Randomised Clinical Control Trial
- ClinicalTrials.gov ID
- NCT05322421
- Acronym / sponsor ID
- FDASU-REC 964123
- Conditions
- Radiation Mucositis, Oral Mucositis (Ulcerative) Due to Radiation, Radiation-Induced Mucositis
- Keywords
- radiation, mucositis, oral, stomatitis, olive oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Salma Hesham ElhoufiUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 11 Apr 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.
This research aims to investigate the effectiveness of topical olive oil application both clinically and biochemically as a suitable affordable treatment modality for prevention and management of radiation oral mucositis and its associated pain for head and neck cancer patients receiving radiotherapy.
Detailed description
Twenty adult patients seeking radiotherapy treatment for head and neck cancer are to be selected. Patients meeting the eligibility criteria are to be equally and randomly allocated in 2 different groups. Group 1 will include10 patients receiving topical olive oil application, twice daily (Experimental arm). Group 2 will include 10 patients receiving Sodium bicarbonate 5% solution, twice daily (Control arm). Both intervention and control groups will start the application of the agents two days before the induction of radiotherapy. Evaluation will be done using World Health Organization (WHO) scale for oral mucositis to record the extent and severity of oral mucositis. Pain and discomfort will be evaluated using Numeric Rating Scale (NRS). Clinical evaluation using both scales will be performed after starting radiotherapy every other week ( after 2 weeks, after 4 weeks and after 6 weeks at the end of the treatment). Patients scores will be recorded at similar intervals. Total Antioxidant Capacity "TAC" will be used to study the biochemical effect of topical olive oil application by evaluating the oxidative stress in the saliva. Saliva samples will be collected from all patients of both groups prior to the beginning of radiotherapy, and a second sample will be collected after six weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is designed as a parallel randomized control clinical trial
| Arm | Type | Receives |
|---|---|---|
| Olive Oil | Experimental | Other: Topical Olive OilWill include10 patients receiving topical olive oil application, twice daily |
| Sodium Bicarbonate | Active comparator | Other: Sodium bicarbonate 5% solutionWill include 10 patients receiving Sodium bicarbonate 5% solution, twice daily |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are aged above 25 years up to 65 years.
- Both genders are eligible.
- Patients with head and neck cancer who are planned to receive radiotherapy either as postoperative (adjuvant after surgery) or definitive therapy.
- Patients planned to receive radiotherapy treatment with a dose of 60-70 Gy.
Key exclusion criteria (7 listed)
- Patients with known sensitivity to olive oil and/or any of its products
- Patients with gingival or oral ulceration or mucositis
- Smokers
- Vulnerable patients (pregnant women, neonates, children, prisoners, persons with physical handicaps or mental disabilities)
- Pregnant and lactating women.
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 Olive OilOlive oil will be placed in 200 ml opaque glass containers. For each application, a new stick with a sponge will be submerged into one of the agents to absorb then coat the tongue, buccal mucosa, lips, and hard palate. Patients will be instructed to refrain form eating for 1 hour after the application | Other | Olive Oil |
| Sodium bicarbonate 5% solutionSodium bicarbonate 5% solution will be placed in 200 ml opaque glass containers. For each application, a new stick with a sponge will be submerged into one of the agents to absorb then coat the tongue, buccal mucosa, lips, and hard palate. Patients will be instructed to refrain form eating for 1 hour after the application | Other | Sodium Bicarbonate |
Primary outcome
Incidence of Oral Radiation mucositis
Time frame: Every other week ( 2 weeks, 4 weeks and 6 at the end of the treatment)
Number of participants who develop Radiation mucositis according to the WHO Scale. (grade 0 indicates that no changes have occurred in the oral cavity and grade 4 indicates the worst level of mucositis )
Grade of oral radiation mucositis
Time frame: Every other week ( 2 weeks, 4 weeks and 6 weeks at the end of the treatment)
Clinical evaluation using the WHO scale will be performed to record the changes in the oral cavity after starting radiotherapy, (grade 0 indicates that no changes have occurred in the oral cavity and grade 4 indicates the worst level of mucositis )
2 secondary outcomes
Post operative pain assessment using Numeric Pain Rating Scale
Time frame: Patients scores will be recorded after starting radiotherapy every other week ( 2 weeks, 4 weeks and 6 weeks at the end of the treatment)
Total antioxidant capacity
Time frame: Salivary samples will be collected at baseline before the induction of radiotherapy and at 6 weeks at the end of the treatment for TAC analysis.
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 2 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Radiation Mucositis
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Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
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RecruitingObservational study
Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)
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Citrus Sinensis Peel Gel for Radiation-Induced Oral Mucositis
Radiation-induced Oral Mucositis, Head and Neck Cancer
Not yet recruitingObservational study
Retrospective Observational Study of Oral Complications and Quality of Life in Head and Neck Cancer Patients Treated With Radiotherapy or Chemoradiotherapy.
Oral Mucositis, Quality of Life
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.
Suzan S Ibrahim, Professor study director
Ain Shams University
Radwa Ragheb, Lecturer study director
Ain Shams University
Salma H Elhoufi principal investigator
Ain Shams 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 Topical Olive Oil and Sodium bicarbonate 5% solution in people with Radiation Mucositis and Oral Mucositis (Ulcerative) Due to Radiation, run by Salma Hesham Elhoufi 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: finished, as of the sponsor's last update on 2 Aug 2024. 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?
Incidence of Oral Radiation mucositis (time frame: Every other week ( 2 weeks, 4 weeks and 6 at the end of the treatment)). 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 2 Aug 2024; AzTrials last refreshed its copy on 26 Oct 2026.