The Use of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer

September 24, 2018 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

  • Cyprus
      • 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
  • 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.
Dietary supplement: thymus honey mouthwash
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.
Dietary supplement: thymus honey mouthwash
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
Dietary supplement: thymus honey mouthwash

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

Cyprus University of Technology

Collaborators

Bank of Cyprus Oncology Centre

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

May 1, 2013

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ACTUAL)

September 1, 2018

Study Registration Dates

First Submitted

April 11, 2013

First Submitted That Met QC Criteria

April 13, 2013

First Posted (ESTIMATE)

April 17, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-HCS-89

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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