MedTrace Logo

The Effectiveness of a Thyme and Honey Spray for Oral Toxicities

NCT04880148 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-12-09

No results posted yet for this study

Summary

Aim: To evaluate the effectiveness of thymus honey on radiation induced-oral mucositis and xerostomia.

Background: Oral mucositis and xerostomia are two of the most severe side effects that head and neck cancer patients confront during and after the completion of radiotherapy. Although several medications are used for their treatment, these fail to provide a fully effective and comprehensive management. Honey and thyme have been studied for the management of various treatment-related side effects.

Design: Α double blinded randomised controlled trial will be used for this study.

Methods: 200 head and neck cancer patients who receive radiotherapy will be included in this study. Patients will be randomised and divided into two equal groups of 100 participants; the intervention group (oral spray with thyme and honey + standard care) and the control group ( placebo spray + standard care). Assessments with xerostomia and oral mucositis scales additionally to 4 self-administered questionnaires will occur in both groups at baseline and then weekly and 6 months following completion of treatment. The duration of the study will be 3 years from the day of approval of this research protocol.

Conditions

  • Cancer of the Head and Neck
  • Xerostomia
  • Oral Mucositis
  • Radiation Toxicity

Interventions

DIETARY_SUPPLEMENT

Thyme and Honey-based oral spray

4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session

DIETARY_SUPPLEMENT

Placebo oral spray

4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session

Sponsors & Collaborators

  • German Oncology Center, Cyprus

    collaborator OTHER

  • Bank of Cyprus Oncology Center BOCOC

    collaborator UNKNOWN

  • Cyprus University of Technology

    lead OTHER

Principal Investigators

  • Andreas Charalambous, PhD · Cyprus University of Technology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2024-06-01
Completion
2024-09-01

Countries

  • Cyprus

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04880148 on ClinicalTrials.gov