No registrations found.
ID
Source
Brief title
Health condition
Salivary glands
Differentiated thyroid carcinoma (DTC)
Radioiodine therapy (I131)
Sponsors and support
Intervention
Outcome measures
Primary outcome
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) in:
- Unstimulated whole saliva
- Stimulated whole saliva
- Stimulated glandular 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 and post I-131 therapy
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
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
- 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
Background summary
N/A
Study objective
N/A
Study design
DTC patients visit the outpatient clinic twice for study visits. The first visit is before the I131 therapy, the second approximately 5 months after I131 therapy.
Intervention
Observational study
Patients visit the outpatient clinic twice for study visits. The following measurements are performed:
- Patients fill out the xerostomia inventory questionnaire
- Whole unstimulated and chewing stimulated saliva is collected
- Thereafter, gland specific (stimulated) saliva is collected
Futhermore, the iodine uptake is measured (semi) quantitatively on the pre therapy whole body scan (WBS), the post therapy WBS and the post therapy SPECT/CT.
T.P. Links
Groningen 9713 GZ
The Netherlands
+31 (0)50 3613744
T.P. Links
Groningen 9713 GZ
The Netherlands
+31 (0)50 3613744
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 patient gives written informed consent for study participation
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4113 |
| NTR-old | NTR4354 |
| CCMO | NL42972.042.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
| OMON | NL-OMON40486 |