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

NCT01833650 | Completed DMC

• 1 other identifier: AC-HCS-89
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Keywords

thyroid cancer; radioiodine treatment; xerostomia; sialadenitis

Outcome Measures

Primary Outcomes (1)

• Grade of sialadenitis

  Change from Baseline grade of sialadenitis at 6 and 24 months

Secondary Outcomes (2)

• Grade of Xerostomia

  Change from Baseline grade of xerostomia at 6 and 24 months

• Level of Health related quality of life

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

Other Outcomes (1)

• Salivary Quantity (Quantitative Salivary Scintigraphy)

  Change from Baseline quantity of saliva at 6 and 24 months

Study Arms (4)

Standard care

NO INTERVENTION

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

Candy plus thymus honey mouthwash 12

EXPERIMENTAL

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

Candy plus thymus honey mouthwash 24

EXPERIMENTAL

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

Candy plus thymus honey mouthwash 1

EXPERIMENTAL

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

Interventions

thymus honey mouthwash DIETARY_SUPPLEMENT

Candy plus thymus honey mouthwash 1; Candy plus thymus honey mouthwash 12; Candy plus thymus honey mouthwash 24

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyprus University of Technology: lead
• Bank of Cyprus Oncology Centre: collaborator

Study Sites (1)

Bank of Cyprus Oncology

Nicosia, 2006, Cyprus

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Xerostomia; Sialadenitis

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andreas Charalambous, PhD

  Cyprus University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Oncology and Palliative Care

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 17, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Locations

CY (1)