Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis in Head and Neck Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 15% Propolis solution | Dietary Supplement | — | UNRESOLVED |
| Placebo Solution | Other | — | UNRESOLVED |
| Standard oral care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Propolis
- description
- Participants received 15% propolis solution in addition to standard oral care during radiotherapy. The solution was diluted in water and used with a swish-and-swallow method four times daily.
- interventionNames
- Dietary Supplement: 15% Propolis solution
- Other: Standard oral care
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants received placebo solution in addition to standard oral care during radiotherapy. The solution was diluted in water and used with the same swish-and-swallow schedule as the propolis group.
- interventionNames
- Other: Placebo Solution
- Other: Standard oral care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Use of another non-protocol supplement or investigational product for prevention or treatment of oral mucositis * Unable or unwilling to provide written informed consent
References
Publications (0)
Data not yet available