Microbiota, Oral Mucositis, Symptoms and Signs
Conditions
Keywords
head and neck cancer, mucositis, honey, Taiwanese green propolis, intelligent care, Microbiota, Symptoms distress
Brief summary
The investigators plan to conduct a 3-year pioneering care research project for mucositis in cancer patients. These include: (1) an analysis of the incidence and severity of mucositis, severity, treatment methods, and treatment costs; (2) an RCT comparing the effectiveness of honey, Taiwan green propolis, and usual care in mucositis of cancer patients; (3) monitoring of related symptom changes using a smart bracelet device; (4) a measurement of IL-1, IL-6, IL-10, and TNF, Microbiota in saliva, Microbiota in stool and (4) modeling of the trend of mucositis for alertness and search of essential parameters of the complications.
Detailed description
Mucositis is common among cancer patients receiving radiotherapy and chemotherapy. A total of 80-100% of the patients are suffering from the mucositis pain; their regular dieting is disturbed, nutritional status deteriorated, and even treatment discontinued. Some self-paid medications like glutamine have been used to prevent mucositis before and during radiotherapy/chemotherapy. However, the cost of glutamine is relatively high (NT15,000 month/person) and its treatment efficacy and side effects are still to be determined. Randomized controlled trials (RCTs) and experiments have shown that honey and propolis may be used for the management of mucositis. Taiwan is a country of rich agriculture with unique bee products among which the longan honey demonstrates the most significant antibacterial effects; the green propolis has also been proved to comprise antibacterial, anti-inflammatory, and antioxidant effects. However, none of these propolis products have been specifically trialed for the management of mucositis of cancer patients. Bee products have been concerned as potential sources of natural antioxidants such as flavonoids, phenolic acids, and terpenoids. Their potential treatment effects have caught the attention of the medical community. Accumulating evidence is supporting the use of bee products in mucositis caused by chemotherapy, radiotherapy, or both. However, systematic review and meta-analysis have suggested a low quality of the included RCTs, and this affects the applicability of the evidence in the real clinical scenario. The investigators plan to conduct a 3-year pioneering care research project for mucositis in cancer patients. These include: (1) an analysis of the incidence and severity of mucositis, severity, treatment methods, and treatment costs; (2) an RCT comparing the effectiveness of honey, Taiwan green propolis, and usual care in mucositis of cancer patients; (3) monitoring of related symptom changes using a smart bracelet device; (4) a measurement of IL-1, IL-6, IL-10, and TNF Microbiota in saliva, Microbiota in stool and (4) modeling of the trend of mucositis for alertness and search of essential parameters of the complications. In the first year, our project will focus on the analysis of the incidence and severity of mucositis, treatment methods, and treatment costs. In the second year, the planned RCT will be carried out and changes in heart rate, stress, and fatigue of the patients are to be collected using the smart bracelet. In the third year, the investigators will conduct a deep machine learning of the clinical and serial test data to predict the changes in symptoms. The modeling is anticipated to provide important parameter combinations that assist the alerting of possible severe complications. The overall findings of this project shall the strategical references for applying bee products in the prevention and treatment of mucositis in cancer patients.
Interventions
DIETARY_SUPPLEMENThoney
Since the patient received radiation therapy, Taiwan Longan Honey has been used for a total of eight weeks. Understand the changes of oral mucositis and various symptoms during this period
DIETARY_SUPPLEMENTpropolis
Since the patient received radiation therapy, Taiwan green propolis has been used for a total of eight weeks. Understand the changes of oral mucositis and various symptoms during this period
BEHAVIORALControl
usual care
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
\- age≧20 years old diagnosed as head and neck cancer patients Plan to Receive radiation therapy Consciousness, ability to complete research assessment and willing to participate in research Patients can be communicated in Mandarin and Taiwanese, and complete the questionnaire on their own or with the help of researchers.
Exclusion criteria
\- History of allergic to honey, propolis, various pollen, alcohol People with mental disorders or cognitive dysfunction Diabetes mellitus Critical of end of life patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oral mucositis | twelve weeks | measurement tool: National Cancer Institute Common Terminology Criteria for Adverse Events and The World Health Organization grading system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Xerostomia | twelve weeks | measurement tool: Xerostomia Questionnaire |
| Functional Assessment of Cancer Therapy Scale- Head and Neck | twelve weeks | measurement tool : Functional Assessment of Cancer Therapy Scale- Head and Neck, for patient's Quality of life (QoL), range from 0 to 100, score 100 means better outcome. |
| fatigue--Brief-Fatigue Inventory | Brief-Fatigue Inventory for two weeks. | measurement tool: Brief-Fatigue Inventory, range 0 to 10, 10 was the worst fatigue. |
| Numerical Rating Scale | twelve weeks | measurement tool:Numerical Rating Scale,for pain status, range from 0 to 10, 10 was the most pain, 0 was no pain. |
| IL-1, IL-6, IL-10,TNF | radiotherapy on Day 0, on the 7th, 14th, 21st day and on an average of 28 st day. | The patient collected this saliva before the start of radiotherapy, on the 7th, 14th, 21st day and at the end of radiation therapy, a total of 5 tubes of saliva at a time |
| Microbiota | baseline and twelve weeks | Microbiota from saliva and stool |
| fatigue--Visual Analogue Scale | Visual Analogue Scale for fatigue for twelve weeks. | measurement tool: Visual Analogue Scale for fatigue, range 0 to 10, 10 was the worst fatigue. |
Contacts
Primary ContactTsai-Wei Huang
Outcome results
None listed