Olive oil mouthwash to reduce mouth sores from head and neck cancer treatment
A Study on the Effectiveness of Olive Oil Mouthwash in Alleviating Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer.
This will try olive oil mouthwash to see if it reduces mouth sores in adults getting radiotherapy or chemoradiotherapy for head and neck cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Chiayi Christian Hospital Academic / other |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Chiayi City, Chia-Yi City) |
| Trial ID | NCT07293013 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial enrolling adults with primary head and neck cancer who are starting radiotherapy or concurrent chemoradiotherapy. Participants are randomized to use an olive oil mouthwash during their radiation-based treatment and are followed through the course of therapy. The study tracks the development, severity, and duration of oral mucositis and collects patient comfort and quality-of-life information. The intervention is compared with usual oral care to determine whether olive oil’s moisturizing and anti-inflammatory properties reduce treatment-related mouth sores.
Who should consider this trial
Good fit: Adults aged 20 or older with primary head and neck cancer scheduled to receive 6000–7200 cGy of radiotherapy or concurrent chemoradiotherapy who can consent and communicate in Mandarin or Taiwanese are the intended participants.
Not a fit: Patients undergoing re‑irradiation for recurrent disease, those with known metastasis, those already with significant oral mucositis at enrollment, or individuals allergic to components of the mouthwash are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, olive oil mouthwash could offer a simple, low-cost way to reduce the severity and discomfort of radiation-induced oral mucositis.
How similar studies have performed: The use of olive oil for oral mucositis is novel and untested, though other pharmacological and non‑pharmacological mouthwashes have shown mixed results in prior work.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. 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 informed consent 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 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.
Where this trial is running
Chiayi City, Chia-Yi City
- Ditmanson Medical Foundation Chiayi Christian Hospital — Chiayi City, Chia-Yi City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chiu-Feng Wu
- Email: 10480@cych.org.tw
- Phone: +886-5-2765041 Ext. 2600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.