An interventional study of olive oil mouthwash in Oral Mucositis in Head and Neck Cancer and Chemo-radiotherapy, sponsored by Chiayi Christian Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Chiayi Christian Hospital · Not applicable, Interventional, and Prevention
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.
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This study's planned enrollment of 120 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
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C. 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 form.
Exclusion Criteria:
A. Patients diagnosed with recurrent head and neck cancer undergoing a second course of radiotherapy or CCRT.
B. Patients who are allergic or have a history of allergy to any component of the intervention used in this study.
C. Patients who are unable to open their mouth due to skin grafting. D. Patients with known (M1). E. Patients who have already developed oral mucositis (OM). F. Patients with skin diseases, disorders, or those deemed unsuitable for the study by the physician.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: 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.
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)
Time frame: 12 Weeks
degree of dry mouth
Assessment tools include XQ and Saxon test
Time frame: 12 weeks
pain severity
Assessment tools VAS
Time frame: 12 Weeks
General Comfort
Assessment tools Shortened General Comfort Questionnaire (SGCQ)
Time frame: 12 Weeks
Plan to share: No
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