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

Cyprus University of Technology

Status: Completed

Conditions: Thyroid Cancer

Treatments: Dietary Supplement: thymus honey mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT01833650

AC-HCS-89

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Standard care

No Intervention group

Description:

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

Candy plus thymus honey mouthwash 12

Experimental group

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.

Treatment:

Dietary Supplement: thymus honey mouthwash

Candy plus thymus honey mouthwash 24

Experimental group

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.

Treatment:

Dietary Supplement: thymus honey mouthwash

Candy plus thymus honey mouthwash 1

Experimental group

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

Treatment:

Dietary Supplement: thymus honey mouthwash