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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833650
• Other study ID #: AC-HCS-89
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

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