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Completed

NCT Number: NCT01833650

The Use 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.

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Salivary Gland Diseases Sialadenitis Stomatognathic Diseases Thyroid Diseases Thyroid Neoplasms Xerostomia

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bank of Cyprus Oncology

Nicosia, 2006, Cyprus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thymus honey mouthwash

Dietary 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.

Primary outcomes

  1. Grade of sialadenitis

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

Secondary outcomes

  1. Grade of Xerostomia

    Time frame: Change from Baseline grade of xerostomia at 6 and 24 months

  2. Level of Health related quality of life

    Time frame: Change from Baseline level of health related quality of life at 6 and 24 months

Other outcomes

  1. Salivary Quantity (Quantitative Salivary Scintigraphy)

    Time frame: Change from Baseline quantity of saliva at 6 and 24 months

Sponsors and collaborators

Lead sponsor

Cyprus University of Technology

Other

Collaborators

  • Bank of Cyprus Oncology Centre

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2013
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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