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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Ankara
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Ankara, Ankara, Турция (Туркие), 06200
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Плацебо Компаратор: 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.
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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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Time to First Severe Oral Mucositis
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Time to First Moderate or Severe Oral Mucositis
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
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Requirement for Oral Nutritional Supplements
Временное ограничение: 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
Временное ограничение: 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.
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From start of radiotherapy to completion of radiotherapy, assessed weekly up to approximately 7 weeks
|
|
Hospitalization for Supportive Care
Временное ограничение: 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.
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From start of radiotherapy to two weeks later than completion of radiotherapy, up to approximately 9 weeks
|
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Clinical Oral Candidiasis
Временное ограничение: 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
|
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Change in Body Weight
Временное ограничение: Baseline to week 4 of radiotherapy
|
Percentage change in body weight from baseline to week 4 of radiotherapy.
|
Baseline to week 4 of radiotherapy
|
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Change in Serum Albumin
Временное ограничение: 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
|
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Change in The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) Global Health Status Score
Временное ограничение: 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.
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Baseline, week 7, and week 12
|
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Change in EORTC QLQ-C30 Functional Scale Scores
Временное ограничение: 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
|
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Change in EORTC QLQ-C30 Symptom Scale and Item Scores
Временное ограничение: 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
|
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Change in EORTC QLQ-H&N35 Symptom Scale Scores
Временное ограничение: 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
|
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Change in EORTC QLQ-H&N35 Single-Item Symptom Scores
Временное ограничение: 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
|
Соавторы и исследователи
Следователи
- Главный следователь: Samet Özlügedik, Prof. MD, PhD, Ankara Oncology Research and Training Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2019-01/183
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