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.
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Ankara
-
Ankara, Ankara, Turecko (Türkiye), 06200
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Propolis
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.
|
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.
Standard oral care included tooth brushing with a soft toothbrush and fluoride toothpaste or denture cleaning, and bicarbonate-based mouthwash after meals.
|
|
Komparátor placeba: Placebo
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.
|
Standard oral care included tooth brushing with a soft toothbrush and fluoride toothpaste or denture cleaning, and bicarbonate-based mouthwash after meals.
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to First Severe Oral Mucositis
Časové okno: 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.
|
From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to First Moderate or Severe Oral Mucositis
Časové okno: 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 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.
|
From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
|
|
Incidence of Dysphagia
Časové okno: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
|
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.
|
From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
|
|
Incidence of Pain
Časové okno: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
|
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.
|
From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
|
|
Requirement for Oral Nutritional Supplements
Časové okno: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
|
Proportion of participants who initiated oral nutritional supplements during radiotherapy.
|
From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
|
|
Time to Initiation of Oral Nutritional Supplements
Časové okno: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
|
Time from the start of radiotherapy to first documented use of oral nutritional supplements.
|
From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
|
|
Hospitalization for Supportive Care
Časové okno: From start of radiotherapy to two weeks later than completion of radiotherapy, up to approximately 9 weeks
|
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.
|
From start of radiotherapy to two weeks later than completion of radiotherapy, up to approximately 9 weeks
|
|
Clinical Oral Candidiasis
Časové okno: From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
|
Proportion of participants diagnosed with clinical oral candidiasis during scheduled clinical assessments.
|
From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
|
|
Change in Body Weight
Časové okno: Baseline to week 4 of radiotherapy
|
Percentage change in body weight from baseline to week 4 of radiotherapy.
|
Baseline to week 4 of radiotherapy
|
|
Change in Serum Albumin
Časové okno: Baseline to week 4 of radiotherapy
|
Change in serum albumin level from baseline to week 4 of radiotherapy, measured in g/L, when clinically available.
|
Baseline to week 4 of radiotherapy
|
|
Change in The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) Global Health Status Score
Časové okno: Baseline, week 7, and week 12
|
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.
|
Baseline, week 7, and week 12
|
|
Change in EORTC QLQ-C30 Functional Scale Scores
Časové okno: Baseline, week 7, and week 12
|
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.
|
Baseline, week 7, and week 12
|
|
Change in EORTC QLQ-C30 Symptom Scale and Item Scores
Časové okno: Baseline, week 7, and week 12
|
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.
|
Baseline, week 7, and week 12
|
|
Change in EORTC QLQ-H&N35 Symptom Scale Scores
Časové okno: Baseline, week 7, and week 12
|
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.
|
Baseline, week 7, and week 12
|
|
Change in EORTC QLQ-H&N35 Single-Item Symptom Scores
Časové okno: Baseline, week 7, and week 12
|
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.
|
Baseline, week 7, and week 12
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Samet Özlügedik, Prof. MD, PhD, Ankara Oncology Research and Training Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2019-01/183
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .