NCT04843644

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

2.3 years

First QC Date

April 12, 2021

Last Update Submit

April 12, 2021

Conditions

Oral MucositisMicrobiotaSymptoms and Signs

Keywords

head and neck cancermucositishoneyTaiwanese green propolisintelligent careMicrobiotaSymptoms distress

Outcome Measures

Primary Outcomes (1)

  • oral mucositis

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

    twelve weeks

Secondary Outcomes (7)

  • Numerical Rating Scale

    twelve weeks

  • Xerostomia

    twelve weeks

  • Functional Assessment of Cancer Therapy Scale- Head and Neck

    twelve weeks

  • fatigue--Brief-Fatigue Inventory

    Brief-Fatigue Inventory for two weeks.

  • fatigue--Visual Analogue Scale

    Visual Analogue Scale for fatigue for twelve weeks.

  • +2 more secondary outcomes

Study Arms (3)

honey

EXPERIMENTAL

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.

Dietary Supplement: honey

propolis

EXPERIMENTAL

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.

Dietary Supplement: propolis

control

PLACEBO COMPARATOR

Routine care to encourage oral care three times a day.

Behavioral: Control

Interventions

honeyDIETARY_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

honey
propolisDIETARY_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

propolis
ControlBEHAVIORAL

usual care

control

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- History of allergic to honey, propolis, various pollen, alcohol People with mental disorders or cognitive dysfunction Diabetes mellitus Critical of end of life patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StomatitisSigns and SymptomsHead and Neck NeoplasmsMucositis

Interventions

HoneyPropolis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesResins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex Mixtures

Central Study Contacts

Tsai-Wei Huang

CONTACT

+88627361661tsaiwei@tmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 13, 2021

Study Start

April 10, 2021

Primary Completion

July 31, 2023

Study Completion

July 31, 2025

Last Updated

April 13, 2021

Record last verified: 2021-04