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

Oral Mucositis Clinical Trial

— Mucositis  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05625841
• Other study ID #: N2021100301
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 25, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: Taipei Medical University
• Contact: Tsai-Wei Huang, PhD
• Phone: 886-2-2736-1661
• Email: tsaiwei[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 135
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. diagnosed with a head and neck tumor.

2. receive chemotherapy or radiotherapy.

3. conscious clear and willing to participate in the research.

4. can communicate in Mandarin or Taiwanese.

Exclusion Criteria:

diabetes, arrhythmia, artificial heart rhythm device, allergic to bee products or alcohol.

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Other:
• Honey product
Bee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks.
• propolis
propolis
• Usual care
Usual care

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral mucositis severity	Ulceration or inflammation of the oral mucosa characterizes oral Mucositis	up to 12 weeks
Secondary	pain score	visual analogue score(VAS)	up to 12 weeks
Secondary	fatigue level	Brief Fatigue Inventory	up to 12 weeks
Secondary	Xerostomia score	Xerostomia Inventory	up to 12 weeks
Secondary	nutrition level	Mini Nutritional Assessment	up to 12 weeks
Secondary	QoL questionnaire	FACT-HN	up to 12 weeks
Secondary	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
Secondary	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
Secondary	microbiota level	Stool and oral flora collection	Baseline (Before the start of radiotherapy), week 2, week 4, and up to 12 weeks