The Use of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the use of honey mouthwashes in the prevention of salivary side effects of 131I (radioiodine) therapy.

Official Title
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A Randomized Controlled Trial of the Effectiveness of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer

Conditions
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Thyroid Cancer

Intervention / Treatment
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* Dietary Supplement: thymus honey mouthwash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years old They had a histological diagnosis of papillary, follicular, medullary or anaplastic thyroid cancer They had undergone total thyroidectomy They were able to provide consent Exclusion Criteria: patients who had distant metastases, a history of salivary-gland disorders, collagen tissue disease diabetes mellitus, previous radioiodine therapy or external radiation to the head or neck allergy to the honey
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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>This arm represents the current standard care in patients with thyroid cancer undergoing radioiodine. | |
| Experimental: Candy plus thymus honey mouthwash 12<br>This arm will consist 30 patients and will be the one of the intervention groups where each patient will be instructed to suck 1 or 2 lemon candies every 2-3 h in the daytime plus 4 thymus honey mouthwashes in between (at least one hour after the candy sucking) starting 12 hours after the ingestion of 131I therapy and for a duration of no more than 4 days. | Dietary Supplement: thymus honey mouthwash<br> <br> |
| Experimental: Candy plus thymus honey mouthwash 24<br>This arm will consist 30 patients and will be the one of the intervention groups where each patient will be instructed to suck 1 or 2 lemon candies every 2-3 h in the daytime plus 4 thymus honey mouthwashes in between (at least one hour after the candy sucking) starting 24 hours after the ingestion of 131I therapy and for a duration of no more than 4 days. | Dietary Supplement: thymus honey mouthwash<br> <br> |
| Experimental: Candy plus thymus honey mouthwash 1<br>This arm will consist 30 patients and will be the one of the intervention groups where each patient will be instructed to suck 1 or 2 lemon candies every 2-3 h in the daytime plus 4 thymus honey mouthwashes in between (at least one hour after the candy sucking) starting immediate after the ingestion of 131I therapy (about 1 hour) and for a duration of no more than 4 days | Dietary Supplement: thymus honey mouthwash<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of sialadenitis |  | Change from Baseline grade of sialadenitis at 6 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of Xerostomia |  | Change from Baseline grade of xerostomia at 6 and 24 months | 
| Level of Health related quality of life |  | Change from Baseline level of health related quality of life at 6 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid cancer, radioiodine treatment, xerostomia, sialadenitis