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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-25

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Oral Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Honey

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

Group Type EXPERIMENTAL

Honey product

Intervention Type OTHER

Bee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks.

Honey and propolis

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

Group Type EXPERIMENTAL

Honey product

Intervention Type OTHER

Bee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks.

propolis

Intervention Type OTHER

propolis

Usual care

General routine oral care.

Group Type PLACEBO_COMPARATOR

Usual care

Intervention Type OTHER

Usual care

Interventions

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Honey product

Bee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks.

Intervention Type OTHER

propolis

Intervention Type OTHER

Usual care

Intervention Type OTHER

Eligibility Criteria

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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.