The Effectiveness of a Thyme and Honey Spray for Oral Toxicities (HONEY)

November 26, 2021 updated by: Dr. Andreas Charalambous, Cyprus University of Technology

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a confirmed histologic diagnosis of head and neck cancer
  • Patients referred to non-palliative radiotherapy to the oral cavity will be included in the study
  • Synchronous or induction chemotherapy, or both, will be permitted.
  • Patients aged over 18,
  • Patients able to provide informed consent,
  • Patients having radiotherapy for at least three weeks (lower limit has been set at 50 Gy),
  • Patients able to complete records accurately

Exclusion Criteria:

  • Patients with a confirmed and medically treated diabetes mellitus,
  • Patients with allergy to honey, thyme or any other ingredient,
  • Patients who will refuse to take part in this study and
  • Patients with previous radiotherapy or presence of systemic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thyme and Honey-based oral spray
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
Placebo Comparator: Placebo oral spray
Dietary supplement: Placebo oral spray
4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Mucositis Grade (RTOG) at weekly assessments
Time Frame: Baseline (week 4), week 5, week 6, week 7, week 8 and week 24
The scale includes 5 grades (from 0 to IV). Higher grade denotes more severe mucositis
Baseline (week 4), week 5, week 6, week 7, week 8 and week 24
Change from baseline in Xerostomia Grade (CTCAE) at weekly assessments
Time Frame: Baseline (week 4), week 5, week 6, week 7, week 8 and week 24
he scale includes 5 grades (from 0 to IV). Higher grade denotes more severe xerostomia
Baseline (week 4), week 5, week 6, week 7, week 8 and week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Xerostomia Questionnaire (Dirix et al)
Time Frame: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
consists of three parts. In the first part, patients rate on a 4-likert scale (0, 1, 2, 3) the intensity of xerostomia, oral pain, taste, and dysphagia they experience and whether they suffered from more intense tooth decay or other related problems. Secondly, patients evaluate the impact of xerostomia on their Quality of Life. The Quality of Life (QoL) scales contains 15 items (ranging from 1 to 5) with a higher score indicating a worst QoL level (minimum score is 15 and the maximum is 75). Finally, patients rate the degree to which they suffered from xerostomia on a 100-mm Visual Analogue Scale (VAS).
Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
Change from baseline in Oral Mucositis Questionnaire (OMWQ)
Time Frame: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
The 12-item questionnaire is designed to evaluate the overall wellbeing of the patient relating to OM during the last week. Possible answers are scored on Likert scales containing 5, 7 and 11 points. The first 2 questions assess global health and quality of life (QOL). The questions are rated on a 7-point scale, with 1 indicating very poor and 7 indicating excellent. The fourth question, which is made up of 6 items, addresses the impact of MTS on patient function and includes a 5-point scale, with 0 indicating not limited and 4 indicating unable to do. The remaining 3 questions assess the degree of mouth and throat pain and soreness using an 11-point scale, with 0 indicating no pain or soreness and 10 indicating the worst pain or soreness imaginable or possible.
Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
Change from baseline in health-related QoL (EORTC QLQ-C30) questionnaire
Time Frame: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
The EORTC QLQ-C30 is a cancer-specific self-report questionnaire and comprises a global QOL scale (two items), five functional scales, three symptom scales and six single items. Scores QLQ-C30 are linearly transformed to a scale of 0-100, with a higher score indicating a better level of functioning or global QOL, or a worse level of symptoms or problems
Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
Change from baseline in health-related QoL (EORTC QLQ-H&N43) questionnaire
Time Frame: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
The EORTC QLQ-H&N35 module covers specific head and neck issues, comprises ten single items and seven subscales: swallowing, senses, speech, social eating, social contact and sexuality. QLQ-H&N35 are linearly transformed to a scale of 0-100, with a higher score indicating a better level of functioning or global QOL, or a worse level of symptoms or problem.
Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyprus University of Technology

Collaborators

German Oncology Center, Cyprus
Bank of Cyprus Oncology Center BOCOC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2021

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

November 26, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-HONEY-CUT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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