Adverse effects of radioiodine treatment on salivary glands in patients with thyroid cancer
- Conditions
- Salivary glandsDifferentiated thyroid carcinoma (DTC)Radioiodine therapy (I131)
- Registration Number
- NL-OMON24390
- Lead Sponsor
- T.P. Links, University Medical Center Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. Age at diagnosis is at least 18 years
2. The patient is awaiting radioiodine ablation therapy following DTC diagnosis, or is in follow-up for DTC and awaiting radioiodine therapy for persistent or recurrent disease
Exclusion Criteria
1. A history of Sjögrens syndrome or other salivary gland disease affecting salivary gland function
2. Oral ulceration
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study parameter is difference in stimulated salivary flow rate before and after radioiodine therapy, for 1) whole saliva and 2) glandular saliva. <br><br>Other main study parameters: <br>- Difference in parameters before and after radioiodine therapy: <br> o Whole saliva flow rate (unstimulated) <br> o Sialochemistry (sodium, potassium, chloride, amylase, total protein) in:<br> - Unstimulated whole saliva <br> - Stimulated whole saliva <br> - Stimulated glandular saliva <br> <br>- The correlation between: <br> o Semi-quantitative radioiodine uptake in salivary glands on the pre-therapy WBS and difference in stimulated saliva flow rates pre and post I-131 therapy<br> o Semi-quantitative radioiodine uptake in salivary glands on the post-therapy WBS and difference in stimulated saliva flow rates pre and post I-131 therapy <br> o Quantitative radioiodine uptake in salivary glands on the SPECT/CT and difference in stimulated saliva flow rates pre and post I-131 therapy
- Secondary Outcome Measures
Name Time Method - Difference in Xerostomia Inventory score (questionnaire) before and after radioiodine therapy <br /><br>- Correlation between post-therapy Xerostomia Inventory score and difference in stimulated saliva flow rates pre/post I-131 <br /><br>- Difference in stimulated salivary flow rates in patients with 1 radioiodine cycle as compared with patients with 2 or more radioiodine cycles <br /><br>- Correlation between cumulative radioiodine dose and post-therapy stimulated saliva flow rates