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

Cyprus University of Technology1 site in 1 country120 target enrollmentMay 2013

ConditionsThyroid Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Thyroid Cancer
Sponsor: Cyprus University of Technology
Enrollment: 120
Locations: 1
Primary Endpoint: Grade of sialadenitis
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

September 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Cyprus University of Technology

Responsible Party

Principal Investigator

Dr. Andreas Charalambous

Assistant Professor of Oncology and Palliative Care

Cyprus University of Technology

Eligibility Criteria

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

Outcomes

Primary Outcomes

Grade of sialadenitis

Time Frame: Change from Baseline grade of sialadenitis at 6 and 24 months

Secondary Outcomes

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)