Oral Mucositis Clinical Trial
Official title:
Effects of Honey and Propolis on Head and Neck Cancer Patients With Oral Mucositis: a Randomized Controlled Trial
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.
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