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Trial Title:
Effects for Oral Mucositis Care During Chemoradiotherapy in Cancer Patients: Evaluation of the Bee Products
NCT ID:
NCT05625841
Condition:
Oral Mucositis
Conditions: Official terms:
Mucositis
Stomatitis
Propolis
Conditions: Keywords:
Oral Mucositis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Honey product
Description:
Bee products intervention from the first day of radiation to the end of radiation therapy
duration 8-12 weeks.
Arm group label:
Honey
Arm group label:
Honey and propolis
Intervention type:
Other
Intervention name:
propolis
Description:
propolis
Arm group label:
Honey and propolis
Intervention type:
Other
Intervention name:
Usual care
Description:
Usual care
Arm group label:
Usual care
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.
Criteria for 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.
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Taipei Medical University
Address:
City:
Taipei
Zip:
110
Country:
Taiwan
Contact:
Last name:
Tsai-Wei Huang, PhD
Start date:
November 25, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Taipei Medical University
Agency class:
Other
Source:
Taipei Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05625841
