Oral MucositisNCT04382079
Honey Products for Cancer Patients With Oral Mucositis: a Randomized Controlled Trial
A study testing honey and propolis in people with Oral Mucositis, run by Taipei Medical University at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- honey and propolis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2020to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of allergic to honey, propolis, various pollen, alcohol
- People with mental disorders or cognitive dysfunction
- Diabetes mellitus
- Critical of end of life patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Honey and Propolis on Head and Neck Cancer Patients With Oral Mucositis: a Randomized Controlled Trial
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.
Read the 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 in saliva 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
- Being tested
- honey, propolis
- Keywords
- head and neck cancer, mucositis, honey, Taiwanese green propolis, intelligent care
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: propolis |
| control | No intervention | Routine care to encourage oral care three times a day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral mucositis
measurement tool: National Cancer Institute Common Terminology Criteria for Adverse Events and The World Health Organization grading system
Measured: twelve weeks
Secondary outcomes (6)
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.
Measured: twelve weeks
Xerostomia
measurement tool: Xerostomia Questionnaire
Measured: twelve weeks
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.
Measured: twelve weeks
fatigue--Brief-Fatigue Inventory
measurement tool: Brief-Fatigue Inventory, range 0 to 10, 10 was the worst fatigue.
Measured: Brief-Fatigue Inventory for two weeks.
fatigue--Visual Analogue Scale
measurement tool: Visual Analogue Scale for fatigue, range 0 to 10, 10 was the worst fatigue.
Measured: Visual Analogue Scale for fatigue for twelve weeks.
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
Measured: radiotherapy on Day 0, on the 7th, 14th, 21st day and on an average of 28 st day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start8 Apr 2020
- Primary completion15 Apr 2021
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsai-Wei Huang, PhD, Study chair, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382079
- Sponsor's protocol ID
- N202001041
- Status last verified
- Apr 2020
- First submitted
- 3 May 2020
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: oral mucositis severity, fatigue, pain, quality of life
Publications
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.
PubMed 40424080
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Honey and Propolis on Head and Neck Cancer Patients With Oral Mucositis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04382079
- Acronym / sponsor ID
- N202001041
- Conditions
- Oral Mucositis
- Keywords
- head and neck cancer, mucositis, honey, Taiwanese green propolis, intelligent care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 in saliva 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| honey | Experimental | Dietary Supplement: honeyHoney, 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. |
| propolis | Experimental | Dietary Supplement: propolisOil-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. |
| control | No intervention | –Routine care to encourage oral care three times a day. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- History of allergic to honey, propolis, various pollen, alcohol
- People with mental disorders or cognitive dysfunction
- Diabetes mellitus
- Critical of end of life patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| honeySince 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 | Dietary supplement | honey |
| propolisSince 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 | Dietary supplement | propolis |
Primary outcome
oral mucositis
Time frame: twelve weeks
measurement tool: National Cancer Institute Common Terminology Criteria for Adverse Events and The World Health Organization grading system
6 secondary outcomes
Numerical Rating Scale
Time frame: twelve weeks
Xerostomia
Time frame: twelve weeks
Functional Assessment of Cancer Therapy Scale- Head and Neck
Time frame: twelve weeks
fatigue--Brief-Fatigue Inventory
Time frame: Brief-Fatigue Inventory for two weeks.
fatigue--Visual Analogue Scale
Time frame: Visual Analogue Scale for fatigue for twelve weeks.
IL-1, IL-6, IL-10,TNF
Time frame: radiotherapy on Day 0, on the 7th, 14th, 21st day and on an average of 28 st day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Derived from this study: PubMed 40424080Jen 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.
- Individual participant dataSharing planned: Yes. oral mucositis severity, fatigue, pain, quality of life
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsai-Wei Huang, PhD study chair
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing honey and propolis in people with Oral Mucositis, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral mucositis (time frame: twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04382079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.