Actively Recruiting
A Study on the Effectiveness of Olive Oil Mouthwash in Alleviating Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer
Led by Chiayi Christian Hospital · Updated on 2025-12-18
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the preventive and therapeutic effects of using olive oil as a mouthwash to reduce oral mucositis caused by radiation therapy or concurrent chemoradiotherapy in patients with head and neck cancer. Oral mucositis often leads to dry mouth and infection, which negatively impact patients' comfort and quality of life. The study compares olive oil mouthwash with standard care to see if it can improve these symptoms and quality of life over a 12-week period. Participants in the study are randomized to receive either olive oil mouthwash or standard care. The olive oil mouth rinse involves holding 10 mL of olive oil in the mouth and rinsing for 2 minutes daily, starting from the first day of radiotherapy or chemoradiotherapy until the treatment ends. Participants are instructed not to tilt their heads backward during rinsing and to avoid eating or drinking for 30 minutes afterward. If prescribed, antimicrobial mouthwash is used before the olive oil rinse. During the 12 weeks, researchers assess the severity of oral mucositis, dry mouth, pain levels, patient comfort, and quality of life using various validated tools. Data are collected before and after treatment and analyzed statistically to determine the effects of the olive oil mouthwash. The study includes regular evaluations to monitor symptoms and quality of life, with the primary outcome focused on oral mucositis severity.
CONDITIONS
Brief Title
A Study on the Effectiveness of Olive Oil Mouthwash in Alleviating Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 20 years or older
- Diagnosed with primary head and neck cancer and preparing to undergo radiotherapy or concurrent chemoradiotherapy
- Total prescribed radiotherapy dose between 6000 and 7200 cGy
- Conscious and able to communicate in Mandarin or Taiwanese
- Willing to participate and able to sign informed consent
You will not qualify if you...
- Diagnosed with recurrent head and neck cancer and undergoing a second course of radiotherapy or concurrent chemoradiotherapy
- Allergic or have a history of allergy to any component of the olive oil mouthwash
- Unable to open mouth due to skin grafting
- Known metastasis (M1)
- Already developed oral mucositis
- Have skin diseases, autoimmune disorders, or deemed unsuitable by physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of radiotherapy treatment (approximately up to 6 to 7 weeks)
Participants use an olive oil mouthwash starting on the first day of radiotherapy or concurrent chemoradiotherapy and continue until completion of radiotherapy. The mouthwash is performed as the final step of routine oral hygiene, with specific instructions to rinse for 2 minutes and avoid eating or drinking for 30 minutes afterward.
Visits aligned with radiotherapy schedule
Trial Site Locations
Total: 1 location
1
Ditmanson Medical Foundation Chiayi Christian Hospital
Chiayi City, Chia-Yi City, Taiwan, 60002
Actively Recruiting
Research Team
C
Chiu-Feng Wu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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