Clinical trial NCT05625841: Effects for Oral Mucositis Care During Chemoradiotherapy in Cancer Patients: Evaluation of the Bee Products
Official title: Prevention and Improvement for Oral Mucositis Care During Chemoradiotherapy in Head and Neck Cancer Patients With Honey Production
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Mucositis
Keywords: Oral Mucositis
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 135
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: oral mucositis severity
timeFrame: up to 12 weeks
Secondary outcomes:
measure: pain score
timeFrame: up to 12 weeks
measure: fatigue level
timeFrame: up to 12 weeks
measure: Xerostomia score
timeFrame: up to 12 weeks
measure: nutrition level
timeFrame: up to 12 weeks
measure: QoL questionnaire
timeFrame: up to 12 weeks
measure: smart bracelet data
timeFrame: The first week, the fourth week, the 8th week start wearing the smart bracelet for 7 days
measure: Saliva specimen collection
timeFrame: This saliva is collected Baseline (before the start of radiotherapy), week 1, week 2, week 3, and up to 12 weeks
measure: microbiota level
timeFrame: Baseline (Before the start of radiotherapy), week 2, week 4, and up to 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Tsai-Wei Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: