Prevention and Improvement for Oral Mucositis Care During Chemoradiotherapy in Head and Neck Cancer Patients With Honey Production
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oral Mucositis
- Sponsor
- Taipei Medical University
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- oral mucositis severity
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
oral mucositis severity
Time Frame: up to 12 weeks
Ulceration or inflammation of the oral mucosa characterizes oral Mucositis
Secondary Outcomes
- fatigue level(up to 12 weeks)
- nutrition level(up to 12 weeks)
- Saliva specimen collection(This saliva is collected Baseline (before the start of radiotherapy), week 1, week 2, week 3, and up to 12 weeks)
- pain score(up to 12 weeks)
- Xerostomia score(up to 12 weeks)
- QoL questionnaire(up to 12 weeks)
- microbiota level(Baseline (Before the start of radiotherapy), week 2, week 4, and up to 12 weeks)
- smart bracelet data(The first week, the fourth week, the 8th week start wearing the smart bracelet for 7 days)