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Completed

NCT Number: NCT02375451

Effect of Childhood Radioiodine Therapy on Salivary Function

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.

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Key information

Conditions

Xerostomia Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Hyperthyroidism Mouth Diseases Neoplasms Neoplasms by Site Salivary Gland Diseases Stomatognathic Diseases Thyroid Cancer Thyroid Diseases Thyroid Neoplasms

Age range

3 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radioiodine

Other

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).

Primary outcomes

  1. Salivary function (MST value)

    Time frame: 0 to 50 years after radioiodine treatment

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

  2. Responses to Dry Mouth Questionnaire

    Time frame: At time of visit up to 4 months thereafter.

    Patient questionnaire/survey

Secondary outcomes

  1. Caries history (number of caries noted in dental records)

    Time frame: 1 year before radioiodine administration to 4 months after study visit.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 2, 2015
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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