Oral mucositis is common among cancer patients receiving radiotherapy and chemotherapy. 80-90% of the patients are suffering from the mucositis pain; poor nutrition and even treatment discontinued. Some self-paid medications like glutamine has been used to prevent mucositis before and during radiotherapy/chemotherapy. Randomized controlled trials have shown that honey and propolis may be used for the management of mucositis. Honey demonstrates the most significant antibacterial effects; the green propolis has also been proved to comprise antibacterial, anti-inflammatory, and antioxidant effects. Bee products have been concerned as potential sources of natural antioxidants such as flavonoids, phenolic acids, and terpenoids. This study plan to conduct an RCT comparing the effectiveness of honey, honey and green propolis, and usual care in mucositis of cancer patients.
Outcome Measures 1. Questionnaire collection: oral mucositis grade, pain scale, fatigue scale, dry mouth, nutritional status and quality of life scale. 2. Wearing the smart bracelet: The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status. 3. Saliva sample collection: Test the concentration of IL-1, IL-6, IL-10 and TNF in saliva. 4. Stool and oral flora collection: Test stool and oral flora microbiota.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
135
Bee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks.
propolis
Usual care
Taipei Medical University
Taipei, Taiwan
oral mucositis severity
Ulceration or inflammation of the oral mucosa characterizes oral Mucositis
Time frame: up to 12 weeks
pain score
visual analogue score(VAS)
Time frame: up to 12 weeks
fatigue level
Brief Fatigue Inventory
Time frame: up to 12 weeks
Xerostomia score
Xerostomia Inventory
Time frame: up to 12 weeks
nutrition level
Mini Nutritional Assessment
Time frame: up to 12 weeks
QoL questionnaire
FACT-HN
Time frame: up to 12 weeks
smart bracelet data
The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status
Time frame: The first week, the fourth week, the 8th week start wearing the smart bracelet for 7 days
Saliva specimen collection
Test the concentration of IL-1, IL-6, IL-10 and TNF in saliva
Time frame: This saliva is collected Baseline (before the start of radiotherapy), week 1, week 2, week 3, and up to 12 weeks
microbiota level
Stool and oral flora collection
Time frame: Baseline (Before the start of radiotherapy), week 2, week 4, and up to 12 weeks
Tsai-Wei Huang, PhD
CONTACT
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