Thyroid CancerNCT01833650
The Use of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer
A study testing thymus honey mouthwash in people with Thyroid Cancer, run by Cyprus University of Technology at 1 site in Cyprus.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- thymus honey mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Feb 2018to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Thyroid Cancer
- Being tested
- thymus honey mouthwash
- Keywords
- thyroid cancer, radioiodine treatment, xerostomia, sialadenitis
- Medical subject headings
- Thyroid Neoplasms, Xerostomia, Sialadenitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thymus honey mouthwashDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | This arm represents the current standard care in patients with thyroid cancer undergoing radioiodine. |
| Candy plus thymus honey mouthwash 12 | Experimental | 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. Receives: Dietary Supplement: thymus honey mouthwash |
| Candy plus thymus honey mouthwash 24 | Experimental | 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. Receives: Dietary Supplement: thymus honey mouthwash |
| Candy plus thymus honey mouthwash 1 | Experimental | 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 Receives: Dietary Supplement: thymus honey mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of sialadenitis
Measured: Change from Baseline grade of sialadenitis at 6 and 24 months
Secondary outcomes (2)
Grade of Xerostomia
Measured: Change from Baseline grade of xerostomia at 6 and 24 months
Level of Health related quality of life
Measured: Change from Baseline level of health related quality of life at 6 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study start1 Feb 2018
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Bank of Cyprus Oncology Centre
- Responsible party
- Principal investigator, Dr. Andreas Charalambous, Cyprus University of Technology
- Investigators
- Andreas Charalambous, PhD, Principal investigator, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833650
- Sponsor's protocol ID
- AC-HCS-89
- Status last verified
- Jul 2026
- First submitted
- 11 Apr 2013
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effectiveness of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer
- ClinicalTrials.gov ID
- NCT01833650
- Acronym / sponsor ID
- AC-HCS-89
- Conditions
- Thyroid Cancer
- Keywords
- thyroid cancer, radioiodine treatment, xerostomia, sialadenitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Collaborators
- Bank of Cyprus Oncology Centre
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –This arm represents the current standard care in patients with thyroid cancer undergoing radioiodine. |
| Candy plus thymus honey mouthwash 12 | Experimental | Dietary Supplement: thymus honey mouthwashThis 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. |
| Candy plus thymus honey mouthwash 24 | Experimental | Dietary Supplement: thymus honey mouthwashThis 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. |
| Candy plus thymus honey mouthwash 1 | Experimental | Dietary Supplement: thymus honey mouthwashThis 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- >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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thymus honey mouthwashBased 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. | Dietary supplement | Candy plus thymus honey mouthwash 1, Candy plus thymus honey mouthwash 12, Candy plus thymus honey mouthwash 24 |
Primary outcome
Grade of sialadenitis
Time frame: Change from Baseline grade of sialadenitis at 6 and 24 months
2 secondary outcomes
Grade of Xerostomia
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Charalambous, PhD principal investigator
Cyprus University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thymus honey mouthwash in people with Thyroid Cancer, run by Cyprus University of Technology at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of sialadenitis (time frame: Change from Baseline grade of sialadenitis at 6 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.