Effect of Childhood Radioiodine Therapy on Salivary Function

Completed

• Conditions: Xerostomia; Hyperthyroidism; Thyroid Cancer
• Interventions: Other: Radioiodine

• Registration Number: NCT02375451
• Lead Sponsor: Boston Children's Hospital

Brief Summary

Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The investigators goals are to answer this question by measuring salivary gland function before and after I-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease.

Detailed Description

Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The investigators goals are to answer this question by measuring salivary gland function before and after I-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease. We will use a Modified Shirmer Test to measure saliva production and a questionnaire to evaluation symptoms of xerostomia.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-02
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients who have been treated with radioiodine therapy
• Patients who have never received radioiodine therapy (negative control group)

Exclusion Criteria

• Non-English speaking subjects will be excluded due to our lack of translation support resources at this time. Of note, participation in our study cannot benefit participants in any way.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radioiodine	Radioiodine	Patients with a history of childhood treatment with radioiodine will be assessed for symptoms of salivary function and measurement of saliva production. These data will be compared to a normal control group.

Primary Outcome Measures

Name	Time	Method
Responses to Dry Mouth Questionnaire	At time of visit up to 4 months thereafter.	Patient questionnaire/survey
Salivary function (MST value)	0 to 50 years after radioiodine treatment	sterile paper strip is used to measure saliva production (noninvasive testing)

Secondary Outcome Measures

Name	Time	Method
Caries history (number of caries noted in dental records)	1 year before radioiodine administration to 4 months after study visit.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States