NCT07597525Completed
Propolis for Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer
Comparison of Local Propolis Application and Placebo in Addition to Standard Oral Care for Radiotherapy-Induced Oral Mucositis: A Randomized, Double-Blind, Placebo-Controlled Trial.
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
This clinical trial evaluated whether a 15% propolis solution could delay or prevent severe oral mucositis in patients with head and neck cancer receiving radiotherapy or concurrent chemoradiotherapy. Oral mucositis is a common and painful side effect of radiotherapy to the head and neck region. It can interfere with eating, swallowing, hydration, pain control, and treatment tolerance. Researchers compared propolis plus standard oral care with placebo plus standard oral care. The main question was whether propolis delayed the first occurrence of severe oral mucositis during radiotherapy. Severe oral mucositis was assessed using the World Health Organization Oral Toxicity Scale. Participants were randomly assigned to receive either 15% propolis solution or placebo. Both solutions were used with the same schedule. Participants diluted 20 drops in 50 mL water and used the assigned solution with a swish-and-swallow method four times daily during radiotherapy. All participants also received standard oral care. Participants had weekly clinical assessments during radiotherapy. Researchers recorded oral mucositis grade, swallowing difficulty, pain, need for oral nutritional supplements, clinical oral candidiasis, hospitalization for supportive care, and other treatment-related outcomes. Quality-of-life questionnaires were completed at planned study visits.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 12 May 2026
- Start date
- 27 May 2019
- Primary completion date
- 26 Sept 2025
- Lead sponsor
- Ankara Oncology Research and Training Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT07597525
What you commit to
- Study type: Interventional
- Participants enrolled: 140
- From 27 May 2019 to the primary completion date, 26 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of another non-protocol supplement or investigational product for prevention or treatment of oral mucositis
Other illness
- Insulin-dependent diabetes mellitus
- Known allergy or hypersensitivity to propolis, bee products, bee stings, or any ingredient of the study solution
- Medical condition preventing safe use of the swish-and-swallow protocol
Other
- Unable or unwilling to provide written informed consent
Who the study is looking for
- Diagnosis of head and neck cancer
- Planned to receive radiotherapy or concurrent chemoradiotherapy to the head and neck region
- Able to use the assigned oral solution with the swish-and-swallow method
- Able to attend weekly clinical assessments during radiotherapy
- Provided written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.