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

Ankara Oncology Research and Training Hospital

Status: Completed

Conditions: Oral Mucositis in Head and Neck Cancer

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

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT07597525

2019-01/183

Details and patient eligibility

About

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.

Full description

Radiotherapy-induced oral mucositis is a frequent and clinically important toxicity in patients receiving radiotherapy or concurrent chemoradiotherapy for head and neck cancer. Severe oral mucositis can cause pain, swallowing difficulty, reduced oral intake, dehydration, need for nutritional support, hospitalization for supportive care, and interruptions in cancer treatment.

Propolis is a resinous bee-derived product containing phenolic compounds and flavonoids. It has been studied for potential anti-inflammatory, antioxidant, antimicrobial, and wound-healing effects. Because these biological properties may be relevant to the pathogenesis of oral mucositis, propolis has been proposed as a candidate supportive care intervention for patients receiving cancer therapy.

This randomized, double-blind, placebo-controlled clinical trial evaluated a commercially available water-soluble 15% propolis solution in patients with head and neck cancer receiving radiotherapy or concurrent chemoradiotherapy. Participants were randomized to receive either propolis or placebo in addition to standard oral care. The assigned solution was diluted in water and used with a swish-and-swallow method four times daily during radiotherapy.

The primary objective was to determine whether 15% propolis solution delayed the first occurrence of severe oral mucositis during radiotherapy. Oral mucositis was graded during scheduled weekly clinical assessments using the World Health Organization Oral Toxicity Scale. The trial also evaluated clinically relevant supportive care outcomes, including swallowing difficulty, pain, oral nutritional supplement use, clinical oral candidiasis, hospitalization for supportive care, and patient-reported quality of life.

The study was conducted as an investigator-initiated supportive care trial. The manufacturer supplied the propolis and placebo solutions free of charge but had no role in study design, participant recruitment, clinical assessments, data collection, data analysis, interpretation of findings, manuscript preparation, or the decision to submit the results for publication.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Propolis

Experimental group

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.

Treatment:

Other: Standard oral care

Dietary Supplement: 15% Propolis solution

Placebo

Placebo Comparator group

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.

Treatment:

Other: Standard oral care

Other: Placebo Solution