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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
120
. 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.
Ditmanson Medical Foundation Chiayi Christian Hospital
Chiayi City, Chia-Yi City, Taiwan
RECRUITINGAssessment 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
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