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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Oral Mucositis
• Intervention / Treatment: Other: Usual care; Other: Honey product; Other: propolis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tsai-Wei Huang, PhD; Phone Number: 6350 886-2-2736-1661; Email: tsaiwei@tmu.edu.tw
• Study Contact Backup: Name: Tsai-Wei Huang, PhD

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University
    • Contact: Tsai-Wei Huang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Tsai-Wei Huang, PhD, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 25, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Oral Mucositis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis; Anti-Infective Agents; Propolis
• Other Study ID Numbers: N2021100301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No