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Effect of Childhood Radioiodine Therapy on Salivary Function

Sponsor
Boston Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02375451
Collaborator
(none)
70
Enrollment
1
Location
24
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Radioiodine

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 Design

Study Type:
Observational
Actual Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Effect of Childhood Radioiodine Therapy on Salivary Function
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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.

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).
Control

Patients who are similar in age to those in the Radioiodine group, but who did not recieve I-131 therapy.

Outcome Measures

Primary Outcome Measures

  1. Salivary function (MST value) [0 to 50 years after radioiodine treatment]

    sterile paper strip is used to measure saliva production (noninvasive testing)

  2. Responses to Dry Mouth Questionnaire [At time of visit up to 4 months thereafter.]

    Patient questionnaire/survey

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston Children's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Boston Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ari Wassner, Director, Thyroid Program, Division of Endocrinology, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT02375451
Other Study ID Numbers:
  • IRB-P00012399
First Posted:
Mar 2, 2015
Last Update Posted:
Jun 26, 2017
Last Verified:
Jun 1, 2017
Additional relevant MeSH terms:
Thyroid Neoplasms
Xerostomia
Hyperthyroidism

Study Results

No Results Posted as of Jun 26, 2017