The Use of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer
Not Applicable
Completed
- Conditions
- Thyroid Cancer
- Interventions
- Dietary Supplement: thymus honey mouthwash
- Registration Number
- NCT01833650
- Lead Sponsor
- Cyprus University of Technology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Candy plus thymus honey mouthwash 1 thymus honey mouthwash 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 Candy plus thymus honey mouthwash 24 thymus honey mouthwash 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. Candy plus thymus honey mouthwash 12 thymus honey mouthwash 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.
- Primary Outcome Measures
Name Time Method Grade of sialadenitis Change from Baseline grade of sialadenitis at 6 and 24 months
- Secondary Outcome Measures
Name Time Method Level of Health related quality of life Change from Baseline level of health related quality of life at 6 and 24 months Grade of Xerostomia Change from Baseline grade of xerostomia at 6 and 24 months
Trial Locations
- Locations (1)
Bank of Cyprus Oncology
🇨🇾Nicosia, Cyprus