Oral MucositisMucositisNCT05625841
Effects for Oral Mucositis Care During Chemoradiotherapy in Cancer Patients: Evaluation of the Bee Products
A study testing Honey product and propolis in people with Oral Mucositis, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Oral mucositis is common among cancer patients receiving radiotherapy and chemotherapy. 80-90% of the patients are suffering from the mucositis pain; poor nutrition and even treatment discontinued. Some self-paid medications like glutamine has been used to prevent mucositis before and during radiotherapy/chemotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Honey product and propolis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Nov 2022to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with a head and neck tumor.
- receive chemotherapy or radiotherapy.
- conscious clear and willing to participate in the research.
- can communicate in Mandarin or Taiwanese.
Who cannot join
- diabetes, arrhythmia, artificial heart rhythm device, allergic to bee products or alcohol.
Trial locations and contacts
1 site in 1 country.
Tsai-Wei Huang, PhD contact
About this study
Official title: Prevention and Improvement for Oral Mucositis Care During Chemoradiotherapy in Head and Neck Cancer Patients With Honey Production
Oral mucositis is common among cancer patients receiving radiotherapy and chemotherapy. 80-90% of the patients are suffering from the mucositis pain; poor nutrition and even treatment discontinued. Some self-paid medications like glutamine has been used to prevent mucositis before and during radiotherapy/chemotherapy. Randomized controlled trials have shown that honey and propolis may be used for the management of mucositis. Honey demonstrates the most significant antibacterial effects; the green propolis has also been proved to comprise antibacterial, anti-inflammatory, and antioxidant effects. Bee products have been concerned as potential sources of natural antioxidants such as flavonoids, phenolic acids, and terpenoids. This study plan to conduct an RCT comparing the effectiveness of honey, honey and green propolis, and usual care in mucositis of cancer patients.
Read the detailed description
Outcome Measures
- Questionnaire collection: oral mucositis grade, pain scale, fatigue scale, dry mouth, nutritional status and quality of life scale.
- Wearing the smart bracelet: The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status.
- Saliva sample collection: Test the concentration of IL-1, IL-6, IL-10 and TNF in saliva.
- Stool and oral flora collection: Test stool and oral flora microbiota.
- Conditions
- Oral Mucositis
- Being tested
- Honey product, propolis, Usual care
- Keywords
- Oral Mucositis
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honey productOther
Bee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks.
propolisOther
propolis
Usual careOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Honey | Experimental | Each pack of 10 grams of honey after three meals a day. Receives: Other: Honey product |
| Honey and propolis | Experimental | Each pack contains 0.7ml of propolis + 9.3g of honey after three meals a day. Receives: Other: Honey product; Other: propolis |
| Usual care | Placebo comparator | General routine oral care. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral mucositis severity
Ulceration or inflammation of the oral mucosa characterizes oral Mucositis
Measured: up to 12 weeks
Secondary outcomes (8)
pain score
visual analogue score(VAS)
Measured: up to 12 weeks
fatigue level
Brief Fatigue Inventory
Measured: up to 12 weeks
Xerostomia score
Xerostomia Inventory
Measured: up to 12 weeks
nutrition level
Mini Nutritional Assessment
Measured: up to 12 weeks
QoL questionnaire
FACT-HN
Measured: up to 12 weeks
smart bracelet data
The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status
Measured: The first week, the fourth week, the 8th week start wearing the smart bracelet for 7 days
Saliva specimen collection
Test the concentration of IL-1, IL-6, IL-10 and TNF in saliva
Measured: This saliva is collected Baseline (before the start of radiotherapy), week 1, week 2, week 3, and up to 12 weeks
microbiota level
Stool and oral flora collection
Measured: Baseline (Before the start of radiotherapy), week 2, week 4, and up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start25 Nov 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsai-Wei Huang, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625841
- Sponsor's protocol ID
- N2021100301
- Acronym
- Mucositis
- Status last verified
- Nov 2022
- First submitted
- 20 Oct 2021
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Improvement for Oral Mucositis Care During Chemoradiotherapy in Head and Neck Cancer Patients With Honey Production
- ClinicalTrials.gov ID
- NCT05625841
- Acronym / sponsor ID
- Mucositis / N2021100301
- Conditions
- Oral Mucositis
- Keywords
- Oral Mucositis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 25 Nov 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Nov 2022 (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.
Oral mucositis is common among cancer patients receiving radiotherapy and chemotherapy. 80-90% of the patients are suffering from the mucositis pain; poor nutrition and even treatment discontinued. Some self-paid medications like glutamine has been used to prevent mucositis before and during radiotherapy/chemotherapy. Randomized controlled trials have shown that honey and propolis may be used for the management of mucositis. Honey demonstrates the most significant antibacterial effects; the green propolis has also been proved to comprise antibacterial, anti-inflammatory, and antioxidant effects. Bee products have been concerned as potential sources of natural antioxidants such as flavonoids, phenolic acids, and terpenoids. This study plan to conduct an RCT comparing the effectiveness of honey, honey and green propolis, and usual care in mucositis of cancer patients.
Detailed description
Outcome Measures
- Questionnaire collection: oral mucositis grade, pain scale, fatigue scale, dry mouth, nutritional status and quality of life scale.
- Wearing the smart bracelet: The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status.
- Saliva sample collection: Test the concentration of IL-1, IL-6, IL-10 and TNF in saliva.
- Stool and oral flora collection: Test stool and oral flora microbiota.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Honey | Experimental | Other: Honey productEach pack of 10 grams of honey after three meals a day. |
| Honey and propolis | Experimental | Other: Honey product, Other: propolisEach pack contains 0.7ml of propolis + 9.3g of honey after three meals a day. |
| Usual care | Placebo comparator | Other: Usual careGeneral routine oral care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with a head and neck tumor.
- receive chemotherapy or radiotherapy.
- conscious clear and willing to participate in the research.
- can communicate in Mandarin or Taiwanese.
Key exclusion criteria (1 listed)
- diabetes, arrhythmia, artificial heart rhythm device, allergic to bee products or alcohol.
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 |
|---|---|---|
| Honey productBee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks. | Other | Honey, Honey and propolis |
| propolispropolis | Other | Honey and propolis |
| Usual careUsual care | Other | Usual care |
Primary outcome
oral mucositis severity
Time frame: up to 12 weeks
Ulceration or inflammation of the oral mucosa characterizes oral Mucositis
8 secondary outcomes
pain score
Time frame: up to 12 weeks
fatigue level
Time frame: up to 12 weeks
Xerostomia score
Time frame: up to 12 weeks
nutrition level
Time frame: up to 12 weeks
QoL questionnaire
Time frame: up to 12 weeks
smart bracelet data
Time frame: The first week, the fourth week, the 8th week start wearing the smart bracelet for 7 days
Saliva specimen collection
Time frame: This saliva is collected Baseline (before the start of radiotherapy), week 1, week 2, week 3, and up to 12 weeks
microbiota level
Time frame: Baseline (Before the start of radiotherapy), week 2, week 4, and up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
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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 contact
Tsai-Wei Huang, PhD principal investigator
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 product 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Nov 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsai-Wei Huang, PhD (886-2-2736-1661 ext. 6350, tsaiwei@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral mucositis severity (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2022.