Effects for Oral Mucositis Care During Chemoradiotherapy in Cancer Patients: Evaluation of the Bee Products

Study Overview
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Brief Summary
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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.

Detailed Description
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Outcome Measures Questionnaire collection: oral mucositis grade, pain scale, fatigue scale, dry mouth, nutritional status and quality of life scale. Wearing the smart bracelet: The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status. Saliva sample collection: Test the concentration of IL-1, IL-6, IL-10 and TNF in saliva. Stool and oral flora collection: Test stool and oral flora microbiota.

Official Title
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Prevention and Improvement for Oral Mucositis Care During Chemoradiotherapy in Head and Neck Cancer Patients With Honey Production

Conditions
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Oral Mucositis

Intervention / Treatment
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* Other: Honey product
* Other: propolis
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with a head and neck tumor. receive chemotherapy or radiotherapy. conscious clear and willing to participate in the research. can communicate in Mandarin or Taiwanese. Exclusion Criteria: diabetes, arrhythmia, artificial heart rhythm device, allergic to bee products or alcohol.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Honey<br>Each pack of 10 grams of honey after three meals a day. | Other: Honey product<br>* Bee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks.<br>|
| Experimental: Honey and propolis<br>Each pack contains 0.7ml of propolis + 9.3g of honey after three meals a day. | Other: Honey product<br>* Bee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks.<br>Other: propolis<br>* propolis<br>|
| Placebo Comparator: Usual care<br>General routine oral care. | Other: Usual care<br>* Usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral mucositis severity | Ulceration or inflammation of the oral mucosa characterizes oral Mucositis | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | visual analogue score(VAS) | up to 12 weeks | 
| fatigue level | Brief Fatigue Inventory | up to 12 weeks | 
| Xerostomia score | Xerostomia Inventory | up to 12 weeks | 
| nutrition level | Mini Nutritional Assessment | up to 12 weeks | 
| QoL questionnaire | FACT-HN | up to 12 weeks | 
| smart bracelet data | The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status | 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 | 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 | Baseline (Before the start of radiotherapy), week 2, week 4, and up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Mucositis