Adverse effects of radioiodine treatment on salivary glands in differentiated thyroid carcinoma patients

Adverse effects of radioiodine treatment on salivary glands in differentiated thyroid carcinoma patients - Radioiodine and salivary glands

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40486

Enrollment

Registered

2013-05-07

Start date

2013-05-13

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sialoadenitis inflammation of a salivary gland due to radioiodine therapy sialoadenitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 3. The subject gives written informed consent for study participation

Exclusion criteria

Exclusion criteria: 1. A history of Sjögrens syndrome or other salivary gland disease affecting salivary gland function 2. Oral ulceration 3. Patient is mentally incapacitated 4. Patient receives recombinant human TSH (rhTSH) prior to I131 treatment

Design outcomes

Primary

Measure	Time frame
The main study parameter is difference in stimulated salivary flow rate before and after radioiodine therapy, for 1) whole saliva and 2) glandular saliva. Other main study parameters: - Difference in parameters before and after radioiodine therapy: o Whole saliva flow rate (unstimulated) o Sialochemistry (sodium, potassium, chloride, amylase, total protein) - Unstimulated whole saliva - Stimulated whole saliva - Stimulated glandular saliva - Left parotid saliva - Right parotid saliva - Submandibular/sublingual saliva - The correlation between: o Semi-quantitative radioiodine uptake in salivary glands on the pre-therapy WBS and difference in stimulated saliva flow rates pre/post I-131 o Semi-quantitative radioiodine uptake in salivary glands on the post-therapy WBS and difference in stimulated saliva flow rates pre/post I-131 o Quantitative radioiodine uptake in salivary glands on the SPECT/CT and difference in stimulated saliva flow rates pre/post I-131	—

Measure

Time frame

The main study parameter is difference in stimulated salivary flow rate before and after radioiodine therapy, for 1) whole saliva and 2) glandular saliva. Other main study parameters: - Difference in parameters before and after radioiodine therapy: o Whole saliva flow rate (unstimulated) o Sialochemistry (sodium, potassium, chloride, amylase, total protein) - Unstimulated whole saliva - Stimulated whole saliva - Stimulated glandular saliva - Left parotid saliva - Right parotid saliva - Submandibular/sublingual saliva - The correlation between: o Semi-quantitative radioiodine uptake in salivary glands on the pre-therapy WBS and difference in stimulated saliva flow rates pre/post I-131 o Semi-quantitative radioiodine uptake in salivary glands on the post-therapy WBS and difference in stimulated saliva flow rates pre/post I-131 o Quantitative radioiodine uptake in salivary glands on the SPECT/CT and difference in stimulated saliva flow rates pre/post I-131

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Secondary

Measure	Time frame
Secondary study parameters: - Difference in Xerostomia Inventory score (questionnaire) before and after radioiodine therapy - Correlation between post-therapy Xerostomia Inventory score and difference in stimulated saliva flow rates pre/post I-131 - Difference in stimulated salivary flow rates in patients with 1 radioiodine cycle as compared with patients with 2 or more radioiodine cycles - Correlation between cumulative radioiodine dose and post-therapy stimulated saliva flow rates	—

Measure

Time frame

Secondary study parameters: - Difference in Xerostomia Inventory score (questionnaire) before and after radioiodine therapy - Correlation between post-therapy Xerostomia Inventory score and difference in stimulated saliva flow rates pre/post I-131 - Difference in stimulated salivary flow rates in patients with 1 radioiodine cycle as compared with patients with 2 or more radioiodine cycles - Correlation between cumulative radioiodine dose and post-therapy stimulated saliva flow rates

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Countries

Netherlands

Outcome results