NCT05625841

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Taipei Medical University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Oral Mucositis

Interventions

Type	Name	Description
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
OTHER	Usual care	Usual care

Timeline

• Start date: 2022-11-25
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-11-23
• Last updated: 2022-11-23

Locations

1 site across 1 country: Taiwan