Oral Mucositis in Head and Neck CancerNCT07293013
A Study on the Effectiveness of Olive Oil Mouthwash in Alleviating Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer.
A study testing olive oil mouthwash in people with Oral Mucositis in Head and Neck Cancer and Chemo-radiotherapy, run by Chiayi Christian Hospital at 1 site in Taiwan.
Trial summary
Backgroud: Radiation therapy and concurrent chemoradiotherapy are the main treatment methods for patients with head and neck cancer, which often lead to many severe oral mucositis (OM). It is easy to cause dry mouth and infection, which seriously affects the comfort and quality of life of patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Oral Mucositis in Head and Neck Cancer, Chemo-radiotherapy
- What is being tested?
- olive oil mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Dec 2022to Dec 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A. Aged 20 years or older. B. Diagnosed with a primary cancer located in the head and neck region and preparing to undergo radiotherapy or concurrent chemoradiotherapy (CCRT). For the purposes of this study, CCRT is defined as receiving chemotherapy within one week before or after the first day of radiotherapy.
- The total prescribed radiotherapy dose is between 6000 and 7200 cGy. D. Conscious and able to communicate in Mandarin or Taiwanese. E. Willing to participate in the study after receiving an explanation, and capable of signing the informed consent form.
Who cannot join
- Patients diagnosed with recurrent head and neck cancer undergoing a second course of radiotherapy or CCRT.
- Patients who are allergic or have a history of allergy to any component of the intervention used in this study.
- Patients who are unable to open their mouth due to skin grafting. D. Patients with known metastasis (M1). E. Patients who have already developed oral mucositis (OM). F. Patients with skin diseases, autoimmune disorders, or those deemed unsuitable for the study by the physician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Ditmanson Medical Foundation Chiayi Christian Hospital
Chiayi City, Chia-Yi City, 60002
Chiu-Feng Wu, 10480@cych.org.tw
About this study
Backgroud: Radiation therapy and concurrent chemoradiotherapy are the main treatment methods for patients with head and neck cancer, which often lead to many severe oral mucositis (OM). It is easy to cause dry mouth and infection, which seriously affects the comfort and quality of life of patients. There are many pharmacological and non-pharmacological mouthwash solutions in clinical practice, the purpose of which is to reduce bacterial accumulation in order to prevent and improve OM. Olive oil has powerful moisturizing, antioxidant and anti-inflammatory properties. There is no research on the use of olive oil in the prevention or treatment of OM.
Objective: The purpose of this study was to evaluate the preventive and therapeutic effects of olive oil as a mouthwash solution on OM caused by radiation therapy or concurrent chemoradiotherapy.
Read more
Methods: The research design of this study is a randomized controlled trial. Patients from a radiation oncology clinic of a regional teaching hospital in southern China were invited to participate in the study by intentional sampling. The study will be followed for 12 weeks and will collect data before and after treatment with olive oil mouthwash or standard care. Assessment tools include demographic characteristics, severity of OM (RTOG and OMAS), degree of dry mouth (XQ and Saxon test), pain severity(VAS), Shortened General Comfort Questionnaire (SGCQ) and head and neck cancer patients quality of life scale (FACT-H\&N). The research data will be statistically analyzed by SPSS 22.0 statistical software, and the statistical significance is defined as the P value less than 0.05 as the significant level. Statistical methods include 1) Descriptive statistics include times, percentages, averages, standard deviations, etc. 2) Inferential statistics: Chi-square test, independent t-test, paired t-test and Logistic regression were used to compare the post-test data between the experimental group and the control group, and to detect the effectiveness of intervention measures and 3) Using generalized estimating equations (GEE) to predict the effect of interventions (repeated measures) on OM severity, dry mouth, body weight, quality of life and comfort scores.
Expected outcomes: This study aimed to investigate the efficacy of gargling with olive oil in reducing the incidence of OM, severity of OM, severity of dry mouth, severity of pain, and improved patient comfort and quality of life.
- Being tested
- olive oil mouthwash
- Keywords
- Oral Mucositis, Head and Neck Cancer, Chemo-radiotherapy
- 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.
olive oil mouthwashOther
. The procedures and timing of the olive oil mouth rinse were as follows:
A volume of 10 mL of olive oil was held in the mouth and used for rinsing for 2 minutes. Participants were instructed not to tilt their heads backward during rinsing to prevent choking.
At home, the olive oil mouth rinse was performed as the final step of routine oral hygiene. If an antimicrobial mouthwash had been prescribed by the physician, it was used prior to the olive oil rinse.
The olive oil mouth rinse intervention was initiated on the first day of radiotherapy or concurrent chemoradiotherapy (CCRT) and continued until completion of radiotherapy.
Participants were instructed to refrain from eating or drinking for 30 minutes after each olive oil mouth rinse.
| Study group | Role | What they receive |
|---|---|---|
| olive oil mouthwash | Experimental | Not described Receives: Other: olive oil mouthwash |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment severity of OM
The study will be followed for 12 weeks and will collect data before and after treatment with olive oil mouthwash or standard care. Assessment tools include demographic characteristics, severity of OM (RTOG and OMAS)
Measured: 12 Weeks
Secondary outcomes (3)
degree of dry mouth
Assessment tools include XQ and Saxon test
Measured: 12 weeks
pain severity
Assessment tools VAS
Measured: 12 Weeks
General Comfort
Assessment tools Shortened General Comfort Questionnaire (SGCQ)
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start4 Dec 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucositis in Head and Neck CancerStudies 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
- Participants were recruited from the outpatient radiology department of a hospital in southern Taiwan. This study employed a randomized controlled trial (RCT) design in accordance with the research objectives. Microsoft Excel was used to perform random allocation, evenly assigning participants to either the experimental group or the control group. Matching was conducted based on age and cancer type to minimize differences in baseline characteristics between the two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293013
- Sponsor's protocol ID
- IRB2022100
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effectiveness of Olive Oil Mouthwash in Alleviating Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer.
- ClinicalTrials.gov ID
- NCT07293013
- Acronym / sponsor ID
- IRB2022100
- Keywords
- Oral Mucositis, Head and Neck Cancer, Chemo-radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Study start
- 4 Dec 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Dec 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.
Backgroud: Radiation therapy and concurrent chemoradiotherapy are the main treatment methods for patients with head and neck cancer, which often lead to many severe oral mucositis (OM). It is easy to cause dry mouth and infection, which seriously affects the comfort and quality of life of patients. There are many pharmacological and non-pharmacological mouthwash solutions in clinical practice, the purpose of which is to reduce bacterial accumulation in order to prevent and improve OM. Olive oil has powerful moisturizing, antioxidant and anti-inflammatory properties. There is no research on the use of olive oil in the prevention or treatment of OM.
Objective: The purpose of this study was to evaluate the preventive and therapeutic effects of olive oil as a mouthwash solution on OM caused by radiation therapy or concurrent chemoradiotherapy.
Methods: The research design of this study is a randomized controlled trial. Patients from a radiation oncology clinic of a regional teaching hospital in southern China were invited to participate in the study by intentional sampling. The study will be followed for 12 weeks and will collect data before and after treatment with olive oil mouthwash or standard care. Assessment tools include demographic characteristics, severity of OM (RTOG and OMAS), degree of dry mouth (XQ and Saxon test), pain severity(VAS), Shortened General Comfort Questionnaire (SGCQ) and head and neck cancer patients quality of life scale (FACT-H\&N). The research data will be statistically analyzed by SPSS 22.0 statistical software, and the statistical significance is defined as the P value less than 0.05 as the significant level. Statistical methods include 1) Descriptive statistics include times, percentages, averages, standard deviations, etc. 2) Inferential statistics: Chi-square test, independent t-test, paired t-test and Logistic regression were used to compare the post-test data between the experimental group and the control group, and to detect the effectiveness of intervention measures and 3) Using generalized estimating equations (GEE) to predict the effect of interventions (repeated measures) on OM severity, dry mouth, body weight, quality of life and comfort scores.
Expected outcomes: This study aimed to investigate the efficacy of gargling with olive oil in reducing the incidence of OM, severity of OM, severity of dry mouth, severity of pain, and improved patient comfort and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were recruited from the outpatient radiology department of a hospital in southern Taiwan. This study employed a randomized controlled trial (RCT) design in accordance with the research objectives. Microsoft Excel was used to perform random allocation, evenly assigning participants to either the experimental group or the control group. Matching was conducted based on age and cancer type to minimize differences in baseline characteristics between the two groups.
| Arm | Type | Receives |
|---|---|---|
| olive oil mouthwash | Experimental | Other: olive oil mouthwash |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A. Aged 20 years or older. B. Diagnosed with a primary cancer located in the head and neck region and preparing to undergo radiotherapy or concurrent chemoradiotherapy (CCRT). For the purposes of this study, CCRT is defined as receiving chemotherapy within one week before or after the first day of radiotherapy.
- The total prescribed radiotherapy dose is between 6000 and 7200 cGy. D. Conscious and able to communicate in Mandarin or Taiwanese. E. Willing to participate in the study after receiving an explanation, and capable of signing the informed consent form.
Key exclusion criteria (3 listed)
- Patients diagnosed with recurrent head and neck cancer undergoing a second course of radiotherapy or CCRT.
- Patients who are allergic or have a history of allergy to any component of the intervention used in this study.
- Patients who are unable to open their mouth due to skin grafting. D. Patients with known metastasis (M1). E. Patients who have already developed oral mucositis (OM). F. Patients with skin diseases, autoimmune disorders, or those deemed unsuitable for the study by the physician.
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 |
|---|---|---|
| olive oil mouthwash. The procedures and timing of the olive oil mouth rinse were as follows: A volume of 10 mL of olive oil was held in the mouth and used for rinsing for 2 minutes. Participants were instructed not to tilt their heads backward during rinsing to prevent choking. At home, the olive oil mouth rinse was performed as the final step of routine oral hygiene. If an antimicrobial mouthwash had been prescribed by the physician, it was used prior to the olive oil rinse. The olive oil mouth rinse intervention was initiated on the first day of radiotherapy or concurrent chemoradiotherapy (CCRT) and continued until completion of radiotherapy. Participants were instructed to refrain from eating or drinking for 30 minutes after each olive oil mouth rinse. | Other | olive oil mouthwash |
Primary outcome
Assessment severity of OM
Time frame: 12 Weeks
The study will be followed for 12 weeks and will collect data before and after treatment with olive oil mouthwash or standard care. Assessment tools include demographic characteristics, severity of OM (RTOG and OMAS)
3 secondary outcomes
degree of dry mouth
Time frame: 12 weeks
pain severity
Time frame: 12 Weeks
General Comfort
Time frame: 12 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 Dec 2025.
- 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 study testing olive oil mouthwash in people with Oral Mucositis in Head and Neck Cancer and Chemo-radiotherapy, run by Chiayi Christian Hospital at 1 site in Taiwan.
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 2 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: looking for participants now, as of the sponsor's last update on 18 Dec 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 Taiwan. 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 Chiu-Feng Wu (+886-5-2765041 Ext. 2600, 10480@cych.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment severity of OM (time frame: 12 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 18 Dec 2025.