Microbiota and Symptom Distress in Head and Neck Cancer Patients Receiving Radiotherapy

Oral Mucositis Clinical Trial

Official title:

Microbiota and Symptom Distress in Patients With Head and Neck Cancer Receiving Radiotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04843644
• Other study ID #: HN cancer microbiota RT
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 10, 2021
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2021
• Source: Taipei Medical University
• Contact: Tsai-Wei Huang
• Phone: +88627361661
• Email: tsaiwei[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Microbiota
• Mucositis
• Oral Mucositis
• Stomatitis
• Symptoms and Signs

Intervention

Dietary Supplement:
• honey
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
• propolis
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

Behavioral:
• Control
usual care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral mucositis	measurement tool: National Cancer Institute Common Terminology Criteria for Adverse Events and The World Health Organization grading system	twelve weeks
Secondary	Numerical Rating Scale	measurement tool:Numerical Rating Scale,for pain status, range from 0 to 10, 10 was the most pain, 0 was no pain.	twelve weeks
Secondary	Xerostomia	measurement tool: Xerostomia Questionnaire	twelve weeks
Secondary	Functional Assessment of Cancer Therapy Scale- Head and Neck	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.	twelve weeks
Secondary	fatigue--Brief-Fatigue Inventory	measurement tool: Brief-Fatigue Inventory, range 0 to 10, 10 was the worst fatigue.	Brief-Fatigue Inventory for two weeks.
Secondary	fatigue--Visual Analogue Scale	measurement tool: Visual Analogue Scale for fatigue, range 0 to 10, 10 was the worst fatigue.	Visual Analogue Scale for fatigue for twelve weeks.
Secondary	IL-1, IL-6, IL-10,TNF	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	radiotherapy on Day 0, on the 7th, 14th, 21st day and on an average of 28 st day.
Secondary	Microbiota	Microbiota from saliva and stool	baseline and twelve weeks