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| Name | Class |
|---|---|
| Bank of Cyprus Oncology Centre | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | No Intervention | This arm represents the current standard care in patients with thyroid cancer undergoing radioiodine. | |
| Candy plus thymus honey mouthwash 12 | Experimental | 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. |
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| Candy plus thymus honey mouthwash 24 | Experimental | 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. |
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| Candy plus thymus honey mouthwash 1 | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thymus honey mouthwash | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade of sialadenitis | Change from Baseline grade of sialadenitis at 6 and 24 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Quantity (Quantitative Salivary Scintigraphy) | Change from Baseline quantity of saliva at 6 and 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Charalambous, PhD | Cyprus University of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bank of Cyprus Oncology | Nicosia | 2006 | Cyprus |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D014987 | Xerostomia |
| D012793 | Sialadenitis |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |