Effects for Oral Mucositis Care During Chemoradiotherapy in Cancer Patients: Evaluation of the Bee Products
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Honey Each pack of 10 grams of honey after three meals a day. |
Other: Honey product
Bee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks.
|
| Experimental: Honey and propolis Each pack contains 0.7ml of propolis + 9.3g of honey after three meals a day. |
Other: Honey product
Bee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks.
Other: propolis
propolis
|
| Placebo Comparator: Usual care General routine oral care. |
Other: Usual care
Usual care
|
Outcome Measures
Primary Outcome Measures
- oral mucositis severity [up to 12 weeks]
Ulceration or inflammation of the oral mucosa characterizes oral Mucositis
Secondary Outcome Measures
- pain score [up to 12 weeks]
visual analogue score(VAS)
- fatigue level [up to 12 weeks]
Brief Fatigue Inventory
- Xerostomia score [up to 12 weeks]
Xerostomia Inventory
- nutrition level [up to 12 weeks]
Mini Nutritional Assessment
- QoL questionnaire [up to 12 weeks]
FACT-HN
- smart bracelet data [The first week, the fourth week, the 8th week start wearing the smart bracelet for 7 days]
The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status
- Saliva specimen collection [This saliva is collected Baseline (before the start of radiotherapy), week 1, week 2, week 3, and up to 12 weeks]
Test the concentration of IL-1, IL-6, IL-10 and TNF in saliva
- microbiota level [Baseline (Before the start of radiotherapy), week 2, week 4, and up to 12 weeks]
Stool and oral flora collection
Eligibility Criteria
Criteria
Inclusion Criteria:
-
diagnosed with a head and neck tumor.
-
receive chemotherapy or radiotherapy.
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conscious clear and willing to participate in the research.
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can communicate in Mandarin or Taiwanese.
Exclusion Criteria:
diabetes, arrhythmia, artificial heart rhythm device, allergic to bee products or alcohol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taipei Medical University | Taipei | Taiwan | 110 |
Sponsors and Collaborators
- Taipei Medical University
Investigators
- Principal Investigator: Tsai-Wei Huang, PhD, Taipei Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- N2021100301