Thyroid Cancer Clinical Trial
Official title:
A Randomized Controlled Trial of the Effectiveness of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer
NCT number | NCT01833650 |
Other study ID # | AC-HCS-89 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | September 2018 |
Verified date | September 2018 |
Source | Cyprus University of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | September 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Cyprus | Bank of Cyprus Oncology | Nicosia |
Lead Sponsor | Collaborator |
---|---|
Cyprus University of Technology | Bank of Cyprus Oncology Centre |
Cyprus,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Salivary Quantity (Quantitative Salivary Scintigraphy) | Change from Baseline quantity of saliva at 6 and 24 months | ||
Primary | Grade of sialadenitis | Change from Baseline grade of sialadenitis at 6 and 24 months | ||
Secondary | Grade of Xerostomia | Change from Baseline grade of xerostomia at 6 and 24 months | ||
Secondary | Level of Health related quality of life | Change from Baseline level of health related quality of life at 6 and 24 months |
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