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

Primary Purpose

Oral Mucositis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Honey product
propolis
Usual care
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis focused on measuring Oral Mucositis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diagnosed with a head and neck tumor. receive chemotherapy or radiotherapy. conscious clear and willing to participate in the research. can communicate in Mandarin or Taiwanese. Exclusion Criteria: diabetes, arrhythmia, artificial heart rhythm device, allergic to bee products or alcohol.

Sites / Locations

  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Honey

Honey and propolis

Usual care

Arm Description

Each pack of 10 grams of honey after three meals a day.

Each pack contains 0.7ml of propolis + 9.3g of honey after three meals a day.

General routine oral care.

Outcomes

Primary Outcome Measures

oral mucositis severity
Ulceration or inflammation of the oral mucosa characterizes oral Mucositis

Secondary Outcome Measures

pain score
visual analogue score(VAS)
fatigue level
Brief Fatigue Inventory
Xerostomia score
Xerostomia Inventory
nutrition level
Mini Nutritional Assessment
QoL questionnaire
FACT-HN
smart bracelet data
The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status
Saliva specimen collection
Test the concentration of IL-1, IL-6, IL-10 and TNF in saliva
microbiota level
Stool and oral flora collection

Full Information

First Posted
October 20, 2021
Last Updated
November 22, 2022
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05625841
Brief Title
Effects for Oral Mucositis Care During Chemoradiotherapy in Cancer Patients: Evaluation of the Bee Products
Acronym
Mucositis
Official Title
Prevention and Improvement for Oral Mucositis Care During Chemoradiotherapy in Head and Neck Cancer Patients With Honey Production
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 25, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Oral Mucositis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Honey
Arm Type
Experimental
Arm Description
Each pack of 10 grams of honey after three meals a day.
Arm Title
Honey and propolis
Arm Type
Experimental
Arm Description
Each pack contains 0.7ml of propolis + 9.3g of honey after three meals a day.
Arm Title
Usual care
Arm Type
Placebo Comparator
Arm Description
General routine oral care.
Intervention Type
Other
Intervention Name(s)
Honey product
Intervention Description
Bee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks.
Intervention Type
Other
Intervention Name(s)
propolis
Intervention Description
propolis
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
oral mucositis severity
Description
Ulceration or inflammation of the oral mucosa characterizes oral Mucositis
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
pain score
Description
visual analogue score(VAS)
Time Frame
up to 12 weeks
Title
fatigue level
Description
Brief Fatigue Inventory
Time Frame
up to 12 weeks
Title
Xerostomia score
Description
Xerostomia Inventory
Time Frame
up to 12 weeks
Title
nutrition level
Description
Mini Nutritional Assessment
Time Frame
up to 12 weeks
Title
QoL questionnaire
Description
FACT-HN
Time Frame
up to 12 weeks
Title
smart bracelet data
Description
The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status
Time Frame
The first week, the fourth week, the 8th week start wearing the smart bracelet for 7 days
Title
Saliva specimen collection
Description
Test the concentration of IL-1, IL-6, IL-10 and TNF in saliva
Time Frame
This saliva is collected Baseline (before the start of radiotherapy), week 1, week 2, week 3, and up to 12 weeks
Title
microbiota level
Description
Stool and oral flora collection
Time Frame
Baseline (Before the start of radiotherapy), week 2, week 4, and up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with a head and neck tumor. receive chemotherapy or radiotherapy. conscious clear and willing to participate in the research. can communicate in Mandarin or Taiwanese. Exclusion Criteria: diabetes, arrhythmia, artificial heart rhythm device, allergic to bee products or alcohol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tsai-Wei Huang, PhD
Phone
886-2-2736-1661
Ext
6350
Email
tsaiwei@tmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Tsai-Wei Huang, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsai-Wei Huang, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsai-Wei Huang, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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