The Effectiveness of a Thyme and Honey Spray for Oral Toxicities

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer of the Head and Neck, Xerostomia, Oral Mucositis, Radiation Toxicity

Intervention / Treatment
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* Dietary Supplement: Thyme and Honey-based oral spray
* Dietary Supplement: Placebo oral spray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Mucositis Grade (RTOG) at weekly assessments | 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 | 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) | 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) | 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 | 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 | 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 |