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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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ClinicalTrials.gov Identifier: NCT01833650
Recruitment Status : Recruiting
First Posted : April 17, 2013
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Bank of Cyprus Oncology Centre
Information provided by (Responsible Party):
Dr. Andreas Charalambous, 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.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Dietary Supplement: thymus honey mouthwash Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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 Start Date : May 2013
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Grade of sialadenitis [ Time Frame: Change from Baseline grade of sialadenitis at 6 and 24 months ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Salivary Quantity (Quantitative Salivary Scintigraphy) [ Time Frame: Change from Baseline quantity of saliva at 6 and 24 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833650


Contacts
Contact: Andreas Charalambous, PhD +35725002011 andreas.charalambous@cut.ac.cy
Contact: Savvas Frangos, MD +35722841300 savvas.frangos@bococ.org.cy

Locations
Cyprus
Bank of Cyprus Oncology Recruiting
Nicosia, Cyprus, 2006
Principal Investigator: Andri Christou, MSc         
Sponsors and Collaborators
Cyprus University of Technology
Bank of Cyprus Oncology Centre
Investigators
Principal Investigator: Andreas Charalambous, PhD Cyprus University of Technology

Responsible Party: Dr. Andreas Charalambous, Assistant Professor of Oncology and Palliative Care, Cyprus University of Technology
ClinicalTrials.gov Identifier: NCT01833650     History of Changes
Other Study ID Numbers: AC-HCS-89
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: February 2017

Keywords provided by Dr. Andreas Charalambous, Cyprus University of Technology:
thyroid cancer
radioiodine treatment
xerostomia
sialadenitis

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms