Oral Mucositis in Head and Neck CancerNCT07597525
Propolis for Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer
A study testing 15% Propolis solution and Standard oral care in people with Oral Mucositis in Head and Neck Cancer, run by Ankara Oncology Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis in Head and Neck Cancer
- What is being tested?
- 15% Propolis solution and Standard oral care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 May 2019to 26 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Ankara, 06200
About this study
Official title: 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.
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.
Read more
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.
Read the detailed 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.
- Conditions
- Oral Mucositis in Head and Neck Cancer
- Being tested
- 15% Propolis solution, Placebo Solution, Standard oral care
- Keywords
- propolis, radiotherapy, oral mucositis, head and neck cancer, chemoradiotherapy, oral care, placebo controlled trial, supportive care
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15% Propolis solutionDietary 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.
Placebo SolutionOther
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.
Standard oral careOther
Standard oral care included tooth brushing with a soft toothbrush and fluoride toothpaste or denture cleaning, and bicarbonate-based mouthwash after meals.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo Solution; Other: Standard oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Time from the start of radiotherapy to the first occurrence of moderate or severe oral mucositis, defined as grade 2 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.
Measured: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
Incidence of Dysphagia
Proportion of participants with dysphagia of grade 2 or higher during radiotherapy, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. The CTCAE grading system ranges from grade 1 to grade 5, with higher grades indicating more severe adverse events.
Measured: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
Incidence of Pain
Proportion of participants with pain of grade 2 or higher during radiotherapy, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. The CTCAE grading system ranges from grade 1 to grade 5, with higher grades indicating more severe adverse events.
Measured: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
Requirement for Oral Nutritional Supplements
Proportion of participants who initiated oral nutritional supplements during radiotherapy.
Measured: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
Time to Initiation of Oral Nutritional Supplements
Time from the start of radiotherapy to first documented use of oral nutritional supplements.
Measured: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
Hospitalization for Supportive Care
Proportion of participants hospitalized from the start of radiotherapy to two weeks after completion of radiotherapy for treatment-related toxicity requiring supportive care, including nutritional support, hydration, analgesic treatment, or general supportive management.
Measured: From start of radiotherapy to two weeks later than completion of radiotherapy, up to approximately 9 weeks
Clinical Oral Candidiasis
Proportion of participants diagnosed with clinical oral candidiasis during scheduled clinical assessments.
Measured: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
Change in Body Weight
Percentage change in body weight from baseline to week 4 of radiotherapy.
Measured: Baseline to week 4 of radiotherapy
Change in Serum Albumin
Change in serum albumin level from baseline to week 4 of radiotherapy, measured in g/L, when clinically available.
Measured: Baseline to week 4 of radiotherapy
Change in The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) Global Health Status Score
Change from baseline in the global health status score measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are linearly transformed to a 0 to 100 scale. Higher scores indicate better global health status and quality of life.
Measured: Baseline, week 7, and week 12
Change in EORTC QLQ-C30 Functional Scale Scores
Change from baseline in functional scale scores measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), including physical, role, emotional, cognitive, and social functioning. Scores are linearly transformed to a 0 to 100 scale. Higher scores indicate better functioning.
Measured: Baseline, week 7, and week 12
Change in EORTC QLQ-C30 Symptom Scale and Item Scores
Change from baseline in symptom scale and single-item scores measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are linearly transformed to a 0 to 100 scale. Higher scores indicate greater symptom burden.
Measured: Baseline, week 7, and week 12
Change in EORTC QLQ-H&N35 Symptom Scale Scores
Change from baseline in head and neck cancer-specific symptom scale scores measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Cancer Module 35 (EORTC QLQ-H\&N35). Scores are linearly transformed to a 0 to 100 scale. Higher scores indicate greater symptom burden.
Measured: Baseline, week 7, and week 12
Change in EORTC QLQ-H&N35 Single-Item Symptom Scores
Change from baseline in head and neck cancer-specific single-item symptom scores measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Cancer Module 35 (EORTC QLQ-H\&N35). Scores are linearly transformed to a 0 to 100 scale. Higher scores indicate greater symptom burden or more problems.
Measured: Baseline, week 7, and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start27 May 2019
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucositis in Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Oncology Research and Training Hospital
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Samet Özlügedik, Prof. MD, PhD, Principal investigator, Ankara Oncology Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597525
- Sponsor's protocol ID
- 2019-01/183
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet decided whether individual participant data will be shared. De-identified individual participant data may be made available from the corresponding author upon reasonable request, subject to institutional approval, ethics requirements, and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07597525
- Acronym / sponsor ID
- 2019-01/183
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ankara Oncology Research and Training HospitalResearch network
- Study start
- 27 May 2019 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Propolis | Experimental | Dietary Supplement: 15% Propolis solution, Other: Standard oral careParticipants 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. |
| Placebo | Placebo comparator | Other: Placebo Solution, Other: Standard oral careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15% Propolis solutionA 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. | Dietary supplement | Propolis |
| Placebo SolutionA 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 | Placebo |
| Standard oral careStandard oral care included tooth brushing with a soft toothbrush and fluoride toothpaste or denture cleaning, and bicarbonate-based mouthwash after meals. | Other | Placebo, Propolis |
Primary outcome
Time to First Severe Oral Mucositis
Time frame: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
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.
14 secondary outcomes
Time to First Moderate or Severe Oral Mucositis
Time frame: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
Incidence of Dysphagia
Time frame: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
Incidence of Pain
Time frame: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
Requirement for Oral Nutritional Supplements
Time frame: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
Time to Initiation of Oral Nutritional Supplements
Time frame: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
Hospitalization for Supportive Care
Time frame: From start of radiotherapy to two weeks later than completion of radiotherapy, up to approximately 9 weeks
Clinical Oral Candidiasis
Time frame: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
Change in Body Weight
Time frame: Baseline to week 4 of radiotherapy
Change in Serum Albumin
Time frame: Baseline to week 4 of radiotherapy
Change in The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) Global Health Status Score
Time frame: Baseline, week 7, and week 12
Change in EORTC QLQ-C30 Functional Scale Scores
Time frame: Baseline, week 7, and week 12
Change in EORTC QLQ-C30 Symptom Scale and Item Scores
Time frame: Baseline, week 7, and week 12
Change in EORTC QLQ-H&N35 Symptom Scale Scores
Time frame: Baseline, week 7, and week 12
Change in EORTC QLQ-H&N35 Single-Item Symptom Scores
Time frame: Baseline, week 7, and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided. It is not yet decided whether individual participant data will be shared. De-identified individual participant data may be made available from the corresponding author upon reasonable request, subject to institutional approval, ethics requirements, and applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samet Özlügedik, Prof. MD, PhD principal investigator
Ankara Oncology Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15% Propolis solution and Standard oral care in people with Oral Mucositis in Head and Neck Cancer, run by Ankara Oncology Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Severe Oral Mucositis (time frame: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.