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

NCT ID: NCT04843644

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-10
• Study Completion Date: 2025-07-31

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.

Conditions

Oral Mucositis; Microbiota; Symptoms and Signs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

honey

Honey, 10 grams per pack, calories 33.4 calories, protein 0.05 grams, fat 0.07 grams, fructose + glucose 7.0 grams, sodium 0 mg.

Usage is three times a day after three meals. After oral care is required before use, use 10 grams of longan honey, circulate in the oral cavity for at least 30 seconds, and slowly swallow. Do not eat, drink, or gargle within 30 minutes of use.

Group Type: EXPERIMENTAL

honey

Intervention Type: DIETARY_SUPPLEMENT

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

Oil-soluble green propolis, propolis 100 mg / mL, dilute green propolis 200 times with edible oil, drink 0.5 mL each time, 3 times a day (a total of 50 mg).

Usage: three times a day, after three meals. After oral care is required before use, draw about 0.5ml of green propolis into the mouth, circulate in the oral cavity for at least 30 seconds, and slowly swallow. Do not eat, drink or gargle within 30 minutes of use.

Group Type: EXPERIMENTAL

propolis

Intervention Type: DIETARY_SUPPLEMENT

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

control

Routine care to encourage oral care three times a day.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: BEHAVIORAL

usual care

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIETARY_SUPPLEMENT

Control

usual care

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Tsai-Wei Huang

Role: CONTACT

tsaiwei@tmu.edu.tw

+88627361661

Other Identifiers

HN cancer microbiota RT

Identifier Type: -

Identifier Source: org_study_id