Primary Objectives 1. To assess whether radioiodine therapy results in hyposalivation, altered saliva composition and xerostomia in DTC patients.2. To assess whether the extent of radioiodine uptake on the pre- and post-therapy WBS and SPECT/CT is…
ID
Source
Brief title
Condition
- Other condition
- Thyroid gland disorders
Synonym
Health condition
sialoadenitis
Research involving
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)
- 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
Secondary outcome
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
Background summary
Differentiated thyroid carcinoma (DTC) is a malignancy with a favorable
survival in the majority of patients. Therefore the adverse effects of DTC
treatment have gained more interest. Radioiodine (I-131) therapy is a standard
therapy for patients with DTC. Salivary glands are known to concentrate
(radio)iodine and are therefore at risk for damage following I-131 therapy,
which can result in decreased saliva flow (hyposalivation) and oral dryness
(xerostomia). Several studies assessed salivary gland function by salivary
gland scintigraphy. However, no studies assessed salivary gland specific saliva
flow and gland specific saliva composition, while these measures directly
reflect damage to the particular salivary gland.
Study objective
Primary Objectives
1. To assess whether radioiodine therapy results in hyposalivation, altered
saliva composition and xerostomia in DTC patients.
2. To assess whether the extent of radioiodine uptake on the pre- and
post-therapy WBS and SPECT/CT is predictive for post-therapy hyposalivation,
alterations in saliva composition and xerostomia.
Secondary Objectives
1. To assess whether outcome of the validated xerostomia inventory
questionnaire correlates with objective saliva flow rate and composition
parameters.
2. To assess when the major salivary gland damage occurs; after the first
radioiodine cycle or is there increasing damage with increasing cumulative
radioiodine dose or number of radioiodine cycles?
Study design
Multicenter prospective observational study
Study burden and risks
The study is without risks for patients, as the saliva collection procedure is
non-invasive. All nuclear scans used in this study are part of standard care.
Patients may benefit from the study. In case the patient has hyposalivation and
complaints of xerostomia, the patient gets advice on how to reduce complaints
and keep a good oral health. If indicated, lubricating agents or more
specialized medical care will be advised.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL42972.042.13 |
| OMON | NL-OMON24390 |