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

Primary Purpose

Thyroid Cancer

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
thymus honey mouthwash
Sponsored by
Cyprus University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thyroid Cancer focused on measuring thyroid cancer, radioiodine treatment, xerostomia, sialadenitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bank of Cyprus Oncology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Standard care

Candy plus thymus honey mouthwash 12

Candy plus thymus honey mouthwash 24

Candy plus thymus honey mouthwash 1

Arm Description

This arm represents the current standard care in patients with thyroid cancer undergoing radioiodine.

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.

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.

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

Outcomes

Primary Outcome Measures

Grade of sialadenitis

Secondary Outcome Measures

Grade of Xerostomia
Level of Health related quality of life

Full Information

First Posted
April 11, 2013
Last Updated
September 24, 2018
Sponsor
Cyprus University of Technology
Collaborators
Bank of Cyprus Oncology Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01833650
Brief Title
The Use of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer
Official Title
A Randomized Controlled Trial of the Effectiveness of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cyprus University of Technology
Collaborators
Bank of Cyprus Oncology Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
thyroid cancer, radioiodine treatment, xerostomia, sialadenitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
This arm represents the current standard care in patients with thyroid cancer undergoing radioiodine.
Arm Title
Candy plus thymus honey mouthwash 12
Arm Type
Experimental
Arm Description
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.
Arm Title
Candy plus thymus honey mouthwash 24
Arm Type
Experimental
Arm Description
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.
Arm Title
Candy plus thymus honey mouthwash 1
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
thymus honey mouthwash
Primary Outcome Measure Information:
Title
Grade of sialadenitis
Time Frame
Change from Baseline grade of sialadenitis at 6 and 24 months
Secondary Outcome Measure Information:
Title
Grade of Xerostomia
Time Frame
Change from Baseline grade of xerostomia at 6 and 24 months
Title
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 Pre-specified Outcome Measures:
Title
Salivary Quantity (Quantitative Salivary Scintigraphy)
Time Frame
Change from Baseline quantity of saliva at 6 and 24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Charalambous, PhD
Organizational Affiliation
Cyprus University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bank of Cyprus Oncology
City
Nicosia
ZIP/Postal Code
2006
Country
Cyprus

12. IPD Sharing Statement

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

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