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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2018
Source Cyprus University of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
thymus honey mouthwash


Locations

Country Name City State
Cyprus Bank of Cyprus Oncology Nicosia

Sponsors (2)

Lead Sponsor Collaborator
Cyprus University of Technology Bank of Cyprus Oncology Centre

Country where clinical trial is conducted

Cyprus, 

Outcome

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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