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Propolis for Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer

NCT07597525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-05-19

No results posted yet for this study

Summary

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

  • Oral Mucositis in Head and Neck Cancer

Interventions

DIETARY_SUPPLEMENT

15% Propolis solution

A commercially available water-soluble 15% propolis solution. Participants diluted 20 drops in 50 mL water and used the solution with a swish-and-swallow method four times daily during radiotherapy.

OTHER

Placebo Solution

A placebo solution supplied in identical amber dropper bottles and administered according to the same dilution and swish-and-swallow schedule as the propolis solution.

OTHER

Standard oral care

Standard oral care included tooth brushing with a soft toothbrush and fluoride toothpaste or denture cleaning, and bicarbonate-based mouthwash after meals.

Sponsors & Collaborators

  • Ankara Oncology Research and Training Hospital

    lead NETWORK

Principal Investigators

  • Samet Özlügedik, Prof. MD, PhD · Ankara Oncology Research and Training Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-27
Primary Completion
2025-09-26
Completion
2025-09-26

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07597525 on ClinicalTrials.gov