NCT04876287: START

Salivary dysfuncTion After Radioiodine Treatment

Completed Last updated 10 May 2021

What this trial tests

trial testing Radioiodine in Thyroid Cancer in 138 participants. Completed in 26 April 2021.

Timeline

2 September 2020

Primary endpoint
26 April 2021

26 April 2021

Quick facts

Lead sponsor	Institut de Radioprotection et de Surete Nucleaire
Status	Completed
Study type	OBSERVATIONAL
Enrollment	138
Start date	2 September 2020
Primary completion	26 April 2021
Estimated completion	26 April 2021
Sites	1 location across France

Drugs / interventions tested

• Radioiodine — full drug profile →

Conditions studied

• Thyroid Cancer — all drugs for Thyroid Cancer →

Sponsor

Institut de Radioprotection et de Surete Nucleaire — full company profile →

Who can join

18 and older, any sex, with Thyroid Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Aim/Introduction:

The treatment of differentiated thyroid cancer includes generally a total thyroidectomy, followed by a radioiodine (131I)-therapy. Due to their ability to concentrate iodine, the salivary glands may present inflammation after administration of 131I, which may be symptomatic, may lead to longer-term chronic abnormalities, resulting in alterations in patients' nutrition and quality of life. The incidence of salivary dysfunctions after 131I-therapy varies considerably between studies due to methodological limitations. Also, the occurrence of these dysfunctions may be linked to increased uptake and/or retention of 131I in the salivary glands and/or individual radiosensitivity. However, no clinical or genetic factors have been identified to date to define patients at risk, allowing the delivered activity to be adapted to the expected risk of salivary dysfunctions. The aims of this study are to estimate the incidence of salivary dysfunctions after 131I-therapy, to characterize patients at risk of developing post-treatment dysfunctions using clinical, biomolecular and biochemical factors, and to validate a dosimetric method to calculate the dose received at the salivary gland level in order to analyse the dose response relationship between exposure of salivary glands to 131I and salivary dysfunctions.

Materials and Methods:

This prospective cohort aims to include 120 patients, candidates for a 131I-therapy in the context of their differentiated thyroid cancer, treated in the Nuclear Medicine department of the Pitié-Salpêtrière hospital (40 and 80 patients in a 1.1GBq and a 3.7GBq dose groups respectively). The follow-up is based on 3 scheduled visits: at inclusion (immediately before 131I therapy), 6months and 18months after treatment. For each visit, questionnaires on salivary disorders (validated French tool), quality of life (HAD-scale, MOS-SF-36), and nutritional status are administered. At inclusion and at T6, saliva samples and individual measurement of the salivary flow, without and with salivary glands stimulation, are performed.

External thermoluminescent dosimeters are placed opposite the salivary glands and at the sternal fork on the treatment's day before radioiodine administration and removed 5days after treatment. From dosimeters, a reconstitution of the dose received at the salivary glands will be established using physical and computational phantoms.

Genetic and epigenetic analyses will be performed to find biomarkers of predisposition to develop salivary disorders after 131I-therapy.

Expected results Inclusion of patients started in September 2020 and are still ongoing. Statistical analyses will study the links between salivary dysfunctions and the 131I dose received by the salivary glands, taking into account associated factors. In addition, impacts on the patients' quality of life will be analysed.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dysfunction of the Salivary and Lacrimal Glands After Radioiodine Therapy for Thyroid Cancer: Results of the START Study After 6-Months of Follow-Up.
   Baudin C, Bressand A, Buffet C, Menegaux F, et al · · 2023 · cited 11× · PMID 37300484 · DOI 10.1089/thy.2023.0090
2. Salivary Dysfunctions and Consequences After Radioiodine Treatment for Thyroid Cancer: Protocol for a Self-Controlled Study (START Study).
   Baudin C, Lussey-Lepoutre C, Bressand A, Buffet C, et al · · 2022 · cited 6× · PMID 35867385 · DOI 10.2196/35565