Clinical trial NCT04843644: Microbiota and Symptom Distress in Head and Neck Cancer Patients Receiving Radiotherapy
Official title: Microbiota and Symptom Distress in Patients With Head and Neck Cancer Receiving Radiotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oral Mucositis
Microbiota
Symptoms and Signs
Keywords: head and neck cancer
mucositis
honey
Taiwanese green propolis
intelligent care
Microbiota
Symptoms distress
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: oral mucositis
timeFrame: twelve weeks
Secondary outcomes:
measure: Numerical Rating Scale
timeFrame: twelve weeks
measure: Xerostomia
timeFrame: twelve weeks
measure: Functional Assessment of Cancer Therapy Scale- Head and Neck
timeFrame: twelve weeks
measure: fatigue--Brief-Fatigue Inventory
timeFrame: Brief-Fatigue Inventory for two weeks.
measure: fatigue--Visual Analogue Scale
timeFrame: Visual Analogue Scale for fatigue for twelve weeks.
measure: IL-1, IL-6, IL-10,TNF
timeFrame: radiotherapy on Day 0, on the 7th, 14th, 21st day and on an average of 28 st day.
measure: Microbiota
timeFrame: baseline and twelve weeks
Other outcomes:
Locations:
Study officials:
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