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      Salivary Dysfunctions and Consequences After Radioiodine Treatment for Thyroid Cancer: Protocol for a Self-Controlled Study (START Study)


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          Following radioiodine ( 131I) therapy of differentiated thyroid cancer, the salivary glands may become inflamed, leading to dysfunctions and decreases in patients’ nutritional status and quality of life. The incidence of these dysfunctions after 131I-therapy is poorly known, and no clinical or genetic factors have been identified to date to define at-risk patients, which would allow 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, and consequences on the quality of life and nutritional status for patients after 131I-therapy; to characterize at-risk patients of developing posttreatment dysfunctions using clinical, biomolecular, and biochemical factors; and to validate a dosimetric method to calculate the dose received at the salivary gland level for analyzing the dose-response relationship between absorbed doses to salivary glands and salivary dysfunctions.


          This prospective study aims to include patients for whom 131I-therapy is indicated as part of the treatment for differentiated thyroid cancer in a Paris hospital (40 and 80 patients in the 1.1 GBq and 3.7 GBq groups, respectively). The follow-up is based on three scheduled visits: at inclusion (T0, immediately before 131I-therapy), and at 6 months (T6) and 18 months (T18) posttreatment. For each visit, questionnaires on salivary dysfunctions (validated French tool), quality of life (Hospital Anxiety and Depression scale, Medical Outcomes Study 36-Item Short Form Survey), and nutritional status (visual analog scale) are administered by a trained clinical research associate. At T0 and T6, saliva samples and individual measurements of the salivary flow, without and with salivary glands stimulation, are performed. External thermoluminescent dosimeters are positioned on the skin opposite the salivary glands and at the sternal fork immediately before 131I administration and removed after 5 days. From the doses recorded by the dosimeters, an estimation of the dose received at the salivary glands will be carried out using physical and computational phantoms. Genetic and epigenetic analyses will be performed to search for potential biomarkers of the predisposition to develop salivary dysfunctions after 131I-therapy.


          A total of 139 patients (99 women, 71.2%; mean age 47.4, SD 14.3 years) were enrolled in the study between September 2020 and April 2021 (45 and 94 patients in the 1.1 GBq and 3.7G Bq groups, respectively). T6 follow-up is complete and T18 follow-up is currently underway. Statistical analyses will assess the links between salivary dysfunctions and absorbed doses to the salivary glands, accounting for associated factors. Moreover, impacts on the patients’ quality of life will be analyzed.


          To our knowledge, this study is the first to investigate the risk of salivary dysfunctions (using both objective and subjective indicators) in relation to organ (salivary glands) doses, based on individual dosimeter records and dose reconstructions. The results will allow the identification of patients at risk of salivary dysfunctions and will permit clinicians to propose a more adapted follow-up and/or countermeasures to adverse effects.

          Trial Registration

          ClinicalTrials.gov NCT04876287; https://clinicaltrials.gov/ct2/show/NCT04876287

          International Registered Report Identifier (IRRID)


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          Most cited references22

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          World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

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            2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer.

            Thyroid nodules are a common clinical problem, and differentiated thyroid cancer is becoming increasingly prevalent. Since the American Thyroid Association's (ATA's) guidelines for the management of these disorders were revised in 2009, significant scientific advances have occurred in the field. The aim of these guidelines is to inform clinicians, patients, researchers, and health policy makers on published evidence relating to the diagnosis and management of thyroid nodules and differentiated thyroid cancer.
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              A review of saliva: normal composition, flow, and function.

              An adequate supply of saliva is critical to the preservation and maintenance of oral tissue. Clinicians often do not value the many benefits of saliva until quantities are decreased. Much is written on the subject of salivary hypofunction, but little attention is paid to normal salivary flow and function. This article is a brief, up-to-date overview of the literature on the basics of normal salivary composition, flow, and function. A review of the literature was conducted using MEDLINE and Healthstar (1944 through 1999); articles were selected for inclusion on the basis of relevance and significance to the clinician.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                July 2022
                22 July 2022
                : 11
                : 7
                : e35565
                [1 ] Ionizing Radiation Epidemiology Laboratory Institute for Radiological Protection and Nuclear Safety Fontenay-aux-Roses France
                [2 ] Department of Nuclear Medicine Sorbonne University Pitié-Salpêtrière Hospital APHP Paris France
                [3 ] Equipe Labellisée par la Ligue Contre le Cancer Paris Research Center Cardiovascular Institut National de la Santé et de la Recherche Médicale, University Paris City Paris France
                [4 ] Amarexia France Paris France
                [5 ] Thyroid and Endocrine Tumors Unit Groupe de Recherche Clinique Tumeurs Thyroïdiennes no. 16 Pitié-Salpêtrière Hospital APHP, Sorbonne University Paris France
                [6 ] Department of General and Endocrine Surgery Pitié-Salpêtrière Hospital APHP Sorbonne University Paris France
                [7 ] Biomedical Imaging Laboratory French National Centre for Scientific Research, Institut National de la Santé et de la Recherche Médicale Sorbonne University Paris France
                [8 ] Internal Dose Assessment Laboratory Institut de Radioprotection et de Sûreté Nucléaire Fontenay-aux-Roses France
                [9 ] Ionizing Radiation Dosimetry Laboratory Institut de Radioprotection et de Sûreté Nucléaire Fontenay-aux-Roses France
                [10 ] Department of Animal Biology, Plant Biology and Ecology Faculty of Biosciences Universitat Autònoma de Barcelona Bellaterra, Catalonia Spain
                Author notes
                Corresponding Author: Clémence Baudin clemence.baudin@ 123456irsn.fr
                Author information
                ©Clémence Baudin, Charlotte Lussey-Lepoutre, Alice Bressand, Camille Buffet, Fabrice Menegaux, Marine Soret, David Broggio, Céline Bassinet, Christelle Huet, Gemma Armengol, Laurence Leenhardt, Marie-Odile Bernier. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 22.07.2022.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 9 December 2021
                : 14 March 2022
                : 4 April 2022
                : 25 April 2022

                radioiodine,thyroid cancer,epidemiology,self-controlled study,salivary gland,lacrimal gland,dysfunction,protocol


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