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

Primary Purpose

Oral Mucositis, Microbiota, Symptoms and Signs

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
honey
propolis
Control
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Mucositis focused on measuring head and neck cancer, mucositis, honey, Taiwanese green propolis, intelligent care, Microbiota, Symptoms distress

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    honey

    propolis

    control

    Arm Description

    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.

    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.

    Routine care to encourage oral care three times a day.

    Outcomes

    Primary Outcome Measures

    oral mucositis
    measurement tool: National Cancer Institute Common Terminology Criteria for Adverse Events and The World Health Organization grading system

    Secondary Outcome Measures

    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.
    Xerostomia
    measurement tool: Xerostomia Questionnaire
    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.
    fatigue--Brief-Fatigue Inventory
    measurement tool: Brief-Fatigue Inventory, range 0 to 10, 10 was the worst fatigue.
    fatigue--Visual Analogue Scale
    measurement tool: Visual Analogue Scale for fatigue, range 0 to 10, 10 was the worst fatigue.
    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
    Microbiota
    Microbiota from saliva and stool

    Full Information

    First Posted
    April 12, 2021
    Last Updated
    April 12, 2021
    Sponsor
    Taipei Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04843644
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 10, 2021 (Anticipated)
    Primary Completion Date
    July 31, 2023 (Anticipated)
    Study Completion Date
    July 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Mucositis, Microbiota, Symptoms and Signs
    Keywords
    head and neck cancer, mucositis, honey, Taiwanese green propolis, intelligent care, Microbiota, Symptoms distress

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    honey
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    propolis
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Description
    Routine care to encourage oral care three times a day.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    honey
    Intervention Description
    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
    Intervention Name(s)
    propolis
    Intervention Description
    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
    Behavioral
    Intervention Name(s)
    Control
    Intervention Description
    usual care
    Primary Outcome Measure Information:
    Title
    oral mucositis
    Description
    measurement tool: National Cancer Institute Common Terminology Criteria for Adverse Events and The World Health Organization grading system
    Time Frame
    twelve weeks
    Secondary Outcome Measure Information:
    Title
    Numerical Rating Scale
    Description
    measurement tool:Numerical Rating Scale,for pain status, range from 0 to 10, 10 was the most pain, 0 was no pain.
    Time Frame
    twelve weeks
    Title
    Xerostomia
    Description
    measurement tool: Xerostomia Questionnaire
    Time Frame
    twelve weeks
    Title
    Functional Assessment of Cancer Therapy Scale- Head and Neck
    Description
    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.
    Time Frame
    twelve weeks
    Title
    fatigue--Brief-Fatigue Inventory
    Description
    measurement tool: Brief-Fatigue Inventory, range 0 to 10, 10 was the worst fatigue.
    Time Frame
    Brief-Fatigue Inventory for two weeks.
    Title
    fatigue--Visual Analogue Scale
    Description
    measurement tool: Visual Analogue Scale for fatigue, range 0 to 10, 10 was the worst fatigue.
    Time Frame
    Visual Analogue Scale for fatigue for twelve weeks.
    Title
    IL-1, IL-6, IL-10,TNF
    Description
    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
    Time Frame
    radiotherapy on Day 0, on the 7th, 14th, 21st day and on an average of 28 st day.
    Title
    Microbiota
    Description
    Microbiota from saliva and stool
    Time Frame
    baseline and twelve weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tsai-Wei Huang
    Phone
    +88627361661
    Email
    tsaiwei@tmu.edu.tw

    12. IPD Sharing Statement

    Learn more about this trial

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

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