Effect of Childhood Radioiodine Therapy on Salivary Function

Thyroid Cancer Clinical Trial

Official title:

Effect of Childhood Radioiodine Therapy on Salivary Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375451
• Other study ID #: IRB-P00012399
• Status: Completed
• Phase: N/A
• First received: October 3, 2014
• Last updated: June 23, 2017
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: June 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperthyroidism
• Thyroid Cancer
• Thyroid Neoplasms
• Xerostomia

Intervention

Other:
• Radioiodine
We will determine if prior radioiodine treatment in childhood impacts salivary function or symptoms. Radioiodine treatment will have been determined by the patient's medical condition and care (NOT assigned by this research study).

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary function (MST value)	sterile paper strip is used to measure saliva production (noninvasive testing)	0 to 50 years after radioiodine treatment
Primary	Responses to Dry Mouth Questionnaire	Patient questionnaire/survey	At time of visit up to 4 months thereafter.
Secondary	Caries history (number of caries noted in dental records)		1 year before radioiodine administration to 4 months after study visit.