search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Adverse effects of radioiodine treatment on salivary glands in patients with thyroid cancer


- candidate number15894
- NTR NumberNTR4354
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-dec-2013
- Secondary IDsNL42972.042.13 
- Public TitleAdverse effects of radioiodine treatment on salivary glands in patients with thyroid cancer
- Scientific TitleAdverse effects of radioiodine treatment on salivary glands in differentiated thyroid carcinoma patients
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria1. 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 criteria1. A history of Sjögrens syndrome or other salivary gland disease affecting salivary gland function
2. Oral ulceration
3. Patient is mentally incapacitated
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 13-mei-2013
- planned closingdate
- Target number of participants80
- InterventionsObservational 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.
- Primary outcomeThe 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
- TimepointsDTC 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.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. T.P. Links
- CONTACT for SCIENTIFIC QUERIESProf. dr. T.P. Links
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD17-dec-2013 - 12-feb-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl