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

Not Applicable

Not yet recruiting

• Conditions: Oral Mucositis
• Interventions: Other: Honey product; Other: Usual care; Other: propolis

• Registration Number: NCT05625841
• Lead Sponsor: Taipei Medical University

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.

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 Timeline

• Study First Submitted: 2021-10-20
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-22
• Last Update Submitted: 2022-11-22
• Study First Posted: 2022-11-23
• Last Update Posted: 2022-11-23
• Study Start: 2022-11-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Honey and propolis	propolis	Each pack contains 0.7ml of propolis + 9.3g of honey after three meals a day.
Honey and propolis	Honey product	Each pack contains 0.7ml of propolis + 9.3g of honey after three meals a day.
Usual care	Usual care	General routine oral care.
Honey	Honey product	Each pack of 10 grams of honey after three meals a day.

Primary Outcome Measures

Name	Time	Method
oral mucositis severity	up to 12 weeks	Ulceration or inflammation of the oral mucosa characterizes oral Mucositis

Secondary Outcome Measures

Name	Time	Method
fatigue level	up to 12 weeks	Brief Fatigue Inventory
pain score	up to 12 weeks	visual analogue score(VAS)
Xerostomia score	up to 12 weeks	Xerostomia Inventory
nutrition level	up to 12 weeks	Mini Nutritional Assessment
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
QoL questionnaire	up to 12 weeks	FACT-HN
microbiota level	Baseline (Before the start of radiotherapy), week 2, week 4, and up to 12 weeks	Stool and oral flora collection
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

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan