The Use of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer
July 27, 2026 updated by: Dr. Andreas Charalambous, Cyprus University of Technology
A Randomized Controlled Trial of the Effectiveness of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nicosia
-
Nicosia, Nicosia, Cyprus, 2006
- Bank of Cyprus Oncology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard care
This arm represents the current standard care in patients with thyroid cancer undergoing radioiodine.
|
|
|
Experimental: Candy plus thymus honey mouthwash 12
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.
|
Based on the intervention, 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.
|
|
Experimental: Candy plus thymus honey mouthwash 24
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.
|
Based on the intervention, 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.
|
|
Experimental: Candy plus thymus honey mouthwash 1
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
|
Based on the intervention, 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Grade of sialadenitis
Time Frame: Change from Baseline grade of sialadenitis at 6 and 24 months
|
Change from Baseline grade of sialadenitis at 6 and 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Grade of Xerostomia
Time Frame: Change from Baseline grade of xerostomia at 6 and 24 months
|
Change from Baseline grade of xerostomia at 6 and 24 months
|
|
Level of Health related quality of life
Time Frame: Change from Baseline level of health related quality of life at 6 and 24 months
|
Change from Baseline level of health related quality of life at 6 and 24 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Salivary Quantity (Quantitative Salivary Scintigraphy)
Time Frame: Change from Baseline quantity of saliva at 6 and 24 months
|
Change from Baseline quantity of saliva at 6 and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Andreas Charalambous, PhD, Cyprus University of Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Actual)
August 1, 2024
Study Completion (Actual)
August 1, 2024
Study Registration Dates
First Submitted
April 11, 2013
First Submitted That Met QC Criteria
April 13, 2013
First Posted (Estimated)
April 17, 2013
Study Record Updates
Last Update Posted (Actual)
July 28, 2026
Last Update Submitted That Met QC Criteria
July 27, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC-HCS-89
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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