NCT04880148

The Effectiveness of a Thyme and Honey Spray for Oral Toxicities

The Effectiveness of a Thyme and Honey Spray for the Management of Oral Mucositis and Xerostomia in Head and Neck Cancer Patients Undergoing Radiotherapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Cyprus University of Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-11-03
• Primary completion: 2024-06-01
• Completion: 2024-09-01
• First posted: 2021-05-10
• Last updated: 2021-12-09

Locations

2 sites across 1 country: Cyprus