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

NCT07597525 | Completed

• 1 other identifier: 2019-01/183
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

propolis; radiotherapy; oral mucositis; head and neck cancer; chemoradiotherapy; oral care; placebo controlled trial; supportive care

Outcome Measures

Primary Outcomes (1)

• Time to First Severe Oral Mucositis

  Time from the start of radiotherapy to the first occurrence of severe oral mucositis, defined as grade 3 or higher according to the World Health Organization Oral Toxicity Scale. The scale ranges from grade 0 to grade 4, with higher grades indicating more severe oral mucositis.

  From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks

Secondary Outcomes (14)

• Time to First Moderate or Severe Oral Mucositis

  From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks

• Incidence of Dysphagia

  From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks

• Incidence of Pain

  From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks

• Requirement for Oral Nutritional Supplements

  From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks

• Time to Initiation of Oral Nutritional Supplements

  From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks

Study Arms (2)

Propolis

EXPERIMENTAL

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.

Dietary Supplement: 15% Propolis solution; Other: Standard oral care

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo Solution; Other: Standard oral care

Interventions

15% Propolis solution DIETARY_SUPPLEMENT

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.

Propolis

Placebo Solution OTHER

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.

Placebo

Standard oral care OTHER

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

Placebo; Propolis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Oncology Research and Training Hospital: lead

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, Ankara, 06200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Samet Özlügedik, Prof. MD, PhD

  Ankara Oncology Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcomes assessors were masked to treatment allocation. Propolis and placebo solutions were supplied in identical amber dropper bottles and administered using the same schedule. The randomization sequence was managed by an independent administrative secretariat. Participants were instructed not to discuss sensory characteristics of the solutions with the assessment team.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Participants were randomized to one of two parallel groups: 15% propolis solution plus standard oral care or placebo plus standard oral care. Both groups used the assigned solution with the same swish-and-swallow schedule during radiotherapy.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: May 27, 2019
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

TU (1)