The Effect of Honey on Xerostomia and Oral Mucositis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the use of pure honey will help in the treatment of radiation induced xerostomia and oral mucositis (symptom management)

Detailed Description
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Radiation-induced mucositis is a normal acute side effect of radiotherapy treatment. Exposure of ionising radiation to oral, pharyngeal and laryngeal mucosa gives rise to radiation epithelitis towards the second and third weeks of conventional fractionated radiotherapy. Likewise, salivary flow may decrease by approximately 50% during the first week of radiotherapy and upwards of 80% by the seventh week of treatment. Acute radiation-induced xerostomia is associated with inflammatory reaction. The study will include an intervention and a control group, one receiving honey prior and after the radiotherapy and the other group not receiving honey at all.

Official Title
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A Randomized Control Trial for the Effect of Honey on Radiotherapy Induced Xerostomia and Oral Mucositis in Patients With Head and Neck Cancers

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Dietary Supplement: Honey mouthwash
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who receive radiotherapy (RT) to the oral cavity will be included in the study. Patients with a confirmed histologic diagnosis of head and neck cancer referred to non-palliative radiotherapy will enter into this trial. aged over 18 receiving radiotherapy for at least four weeks Exclusion Criteria: Allergic to honey confirmed and medically treated diabetes mellitus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: receiving Honey<br>The patients will receive honey mouthwash rinses | Dietary Supplement: Honey mouthwash<br>* The patients in the intervention group will receive honey mouthwash 15 minutes before the radiotherapy session, 15 minutes after and 6 hours after the radiotherapy session<br>|
| Active Comparator: Saline mouthwash<br>The patients in this group will receive saline rinses | Other: Normal Saline<br>* Saline rinses 15 minutes before radiotherapy, 15 minutes after, and 6 hours after radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Xerostomia grades |  | 1 week, 2 weeks, 3 weeks, 4 weeks | 
| Change from baseline in oral mucositis grades |  | 1 week, 2 weeks, 3 weeks, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the General satisfaction of comfort |  | 1 week, 2 week, 3 week, 4 week | 
| Change in baseline weight in one month |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck cancer, radiotherapy induced xerostomia, radiotherapy induced oral mucositis, RCT, symptom management