An interventional study of honey and propolis in Oral Mucositis, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Treatment
The investigators plan to conduct a 3-year pioneering care research project for mucositis in cancer patients. These include: (1) an analysis of the incidence and severity of mucositis, severity, treatment methods, and treatment costs; (2) an RCT comparing the effectiveness of honey, Taiwan green propolis, and usual care in mucositis of cancer patients; (3) monitoring of related symptom changes using a smart bracelet device; (4) a measurement of IL-1, IL-6, IL-10, and TNF in saliva and (4) modeling of the trend of mucositis for alertness and search of essential parameters of the complications.
Mucositis is common among cancer patients receiving radiotherapy and chemotherapy. A total of 80-100% of the patients are suffering from the mucositis pain; their regular dieting is disturbed, nutritional status deteriorated, and even treatment discontinued. Some self-paid medications like glutamine have been used to prevent mucositis before and during radiotherapy/chemotherapy. However, the cost of glutamine is relatively high (NT15,000 month/person) and its treatment efficacy and side effects are still to be determined. Randomized controlled trials (RCTs) and experiments have shown that honey and propolis may be used for the management of mucositis. Taiwan is a country of rich agriculture with unique bee products among which the longan honey demonstrates the most significant antibacterial effects; the green propolis has also been proved to comprise antibacterial, anti-inflammatory, and antioxidant effects. However, none of these propolis products have been specifically trialed for the management of mucositis of cancer patients.
Bee products have been concerned as potential sources of natural antioxidants such as flavonoids, phenolic acids, and terpenoids. Their potential treatment effects have caught the attention of the medical community. Accumulating evidence is supporting the use of bee products in mucositis caused by chemotherapy, radiotherapy, or both. However, systematic review and meta-analysis have suggested a low quality of the included RCTs, and this affects the applicability of the evidence in the real clinical scenario.
The investigators plan to conduct a 3-year pioneering care research project for mucositis in cancer patients. These include: (1) an analysis of the incidence and severity of mucositis, severity, treatment methods, and treatment costs; (2) an RCT comparing the effectiveness of honey, Taiwan green propolis, and usual care in mucositis of cancer patients; (3) monitoring of related symptom changes using a smart bracelet device; (4) a measurement of IL-1, IL-6, IL-10, and TNF in saliva and (4) modeling of the trend of mucositis for alertness and search of essential parameters of the complications. In the first year, our project will focus on the analysis of the incidence and severity of mucositis, treatment methods, and treatment costs. In the second year, the planned RCT will be carried out and changes in heart rate, stress, and fatigue of the patients are to be collected using the smart bracelet. In the third year, the investigators will conduct a deep machine learning of the clinical and serial test data to predict the changes in symptoms. The modeling is anticipated to provide important parameter combinations that assist the alerting of possible severe complications. The overall findings of this project shall the strategical references for applying bee products in the prevention and treatment of mucositis in cancer patients.
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's enrollment of 75 is above the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Honey, 10 grams per pack, calories 33.4 calories, protein 0.05 grams, fat 0.07 grams, fructose + glucose 7.0 grams, sodium 0 mg. Usage is three times a day after three meals. After oral care is required before use, use 10 grams of longan honey, circulate in the oral cavity for at least 30 seconds, and slowly swallow. Do not eat, drink, or gargle within 30 minutes of use.
Dietary Supplement: honey
Oil-soluble green propolis, propolis 100 mg / mL, dilute green propolis 200 times with edible oil, drink 0.5 mL each time, 3 times a day (a total of 50 mg). Usage: three times a day, after three meals. After oral care is required before use, draw about 0.5ml of green propolis into the mouth, circulate in the oral cavity for at least 30 seconds, and slowly swallow. Do not eat, drink or gargle within 30 minutes of use.
Dietary Supplement: propolis
Routine care to encourage oral care three times a day.
Since the patient received radiation therapy, Taiwan Longan Honey has been used for a total of eight weeks. Understand the changes of oral mucositis and various symptoms during this period
Since the patient received radiation therapy, Taiwan green propolis has been used for a total of eight weeks. Understand the changes of oral mucositis and various symptoms during this period
oral mucositis
measurement tool: National Cancer Institute Common Terminology Criteria for Adverse Events and The World Health Organization grading system
Time frame: twelve weeks
Numerical Rating Scale
measurement tool:Numerical Rating Scale,for pain status, range from 0 to 10, 10 was the most pain, 0 was no pain.
Time frame: twelve weeks
Xerostomia
measurement tool: Xerostomia Questionnaire
Time frame: twelve weeks
Functional Assessment of Cancer Therapy Scale- Head and Neck
measurement tool : Functional Assessment of Cancer Therapy Scale- Head and Neck, for patient's Quality of life (QoL), range from 0 to 100, score 100 means better outcome.
Time frame: twelve weeks
fatigue--Brief-Fatigue Inventory
measurement tool: Brief-Fatigue Inventory, range 0 to 10, 10 was the worst fatigue.
Time frame: Brief-Fatigue Inventory for two weeks.
fatigue--Visual Analogue Scale
measurement tool: Visual Analogue Scale for fatigue, range 0 to 10, 10 was the worst fatigue.
Time frame: Visual Analogue Scale for fatigue for twelve weeks.
IL-1, IL-6, IL-10,TNF
The patient collected this saliva before the start of radiotherapy, on the 7th, 14th, 21st day and at the end of radiation therapy, a total of 5 tubes of saliva at a time
Time frame: radiotherapy on Day 0, on the 7th, 14th, 21st day and on an average of 28 st day.
Plan to share: Yes — oral mucositis severity, fatigue, pain, quality of life
Supporting information: Study protocol, Csr
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Taipei Medical University