NCT05625841

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

November 25, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

2.1 years

First QC Date

October 20, 2021

Last Update Submit

November 22, 2022

Conditions

Oral Mucositis

Keywords

Oral Mucositis

Outcome Measures

Primary Outcomes (1)

  • oral mucositis severity

    Ulceration or inflammation of the oral mucosa characterizes oral Mucositis

    up to 12 weeks

Secondary Outcomes (8)

  • pain score

    up to 12 weeks

  • fatigue level

    up to 12 weeks

  • Xerostomia score

    up to 12 weeks

  • nutrition level

    up to 12 weeks

  • QoL questionnaire

    up to 12 weeks

  • +3 more secondary outcomes

Study Arms (3)

Honey

EXPERIMENTAL

Each pack of 10 grams of honey after three meals a day.

Other: Honey product

Honey and propolis

EXPERIMENTAL

Each pack contains 0.7ml of propolis + 9.3g of honey after three meals a day.

Other: Honey productOther: propolis

Usual care

PLACEBO COMPARATOR

General routine oral care.

Other: Usual care

Interventions

Honey productOTHER

Bee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks.

HoneyHoney and propolis
propolisOTHER

propolis

Honey and propolis
Usual careOTHER

Usual care

Usual care

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • diabetes, arrhythmia, artificial heart rhythm device, allergic to bee products or alcohol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Stomatitis

Interventions

Propolis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex Mixtures

Study Officials

  • Tsai-Wei Huang, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsai-Wei Huang, PhD

CONTACT

886-2-2736-1661tsaiwei@tmu.edu.tw

Tsai-Wei Huang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 23, 2022

Study Start

November 25, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 23, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)