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

NCT ID: NCT01833650

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2018-09-30

Brief Summary

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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

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Conditions

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Thyroid Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

thymus honey mouthwash

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type EXPERIMENTAL

thymus honey mouthwash

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

thymus honey mouthwash

Intervention Type DIETARY_SUPPLEMENT

Interventions

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thymus honey mouthwash

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bank of Cyprus Oncology Centre

OTHER

Sponsor Role collaborator

Cyprus University of Technology

OTHER

Sponsor Role lead

Responsible Party

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Dr. Andreas Charalambous

Assistant Professor of Oncology and Palliative Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Charalambous, PhD

Role: PRINCIPAL_INVESTIGATOR

Cyprus University of Technology

Locations

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Bank of Cyprus Oncology

Nicosia, , Cyprus

Site Status

Countries

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Cyprus

Other Identifiers

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AC-HCS-89

Identifier Type: -

Identifier Source: org_study_id

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