Honey Products for Cancer Patients With Oral Mucositis: a Randomized Controlled Trial

NCT04382079 | Completed DMC

• 1 other identifier: N202001041
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 in saliva and (4) modeling of the trend of mucositis for alertness and search of essential parameters of the complications.

Conditions

Oral Mucositis

Keywords

head and neck cancer; mucositis; honey; Taiwanese green propolis; intelligent care

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 (6)

• 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.

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

NO INTERVENTION

Routine care to encourage oral care three times a day.

Interventions

honey 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

honey

propolis 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

propolis

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei County, 110, Taiwan

Location

Related Publications (1)

• Jen SC, Chen YW, Tsai JT, Kuo CC, Ting LL, Huang WY, Huang TW, Chen JH, Gautama MSN. Effects of honey and Taiwanese green propolis on oral mucositis and quality of life in head and neck cancer patients undergoing radiotherapy: a randomized controlled trial. Food Funct. 2025 Jun 16;16(12):4958-4969. doi: 10.1039/d5fo00067j.

  PMID: 40424080 DERIVED

MeSH Terms

Conditions

Stomatitis; Head and Neck Neoplasms; Mucositis

Interventions

Honey; Propolis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Tsai-Wei Huang, PhD

  Taipei Medical University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 11, 2020
• Study Start: April 8, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2022
• Last Updated: March 5, 2025

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Before radiotherapy, until 12 weeks later
• Access Criteria: Professor Huang will review the application to share IPD.

Locations

TW (1)