Salivary dysfuncTion After Radioiodine Treatment

NCT04876287 | Completed

• 1 other identifier: 2020-A00208-31
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Cancer

Keywords

radioiodine; salivary dysfunctions; genetic polymorphism; dosimetry

Outcome Measures

Primary Outcomes (6)

• decrease in salivary flow (mL) after radioiodine therapy

  salivary flows (with and without stimulation of the salivary glands) are measured before and 6 months after the radioiodine treatment. A decrease of 5% of the flows will allow to caracterize the outcome 1

  6 months

• Anxiety and depression symptoms

  The Hospital Anxiety and Depression (HAD) validated scale will be use to assess the outcome 2. The HAD scale is an instrument that screens for anxiety and depressive disorders. It includes 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score = 21). To screen for anxiety and depressive symptomatology, the following interpretation will be adopted for each of the scores (A and D): * 7 or less: no symptomatology * 8 to 10: doubtful symptomatology * 11 and more: definite symptomatology.

  18 months

• Eyes dryness

  The Ocular Surface Disease Index (OSDI) will be use for eye dryness assessment. It is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease severity (normal, mild to moderate, and severe) and effect on vision-related function.

  18 months

• Self-rating Quality of life

  The Medical Outcomes Study (MOS) 36-item short-form (SF-36) includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The arithmetic averaging of the SF-36 domains scores will be used. For each domain, a score will be calculated from 0 to 100, with a greater score indicating a better-perceived health state. These 8 scales wil be compressed into 2 primary summary scales: The physical component scale (PCS) and the mental component scale (MCS). An overall (global) SF-36 score was calculated by summating the 8 dimensions and dividing by 8.

  18 months

• Salivary dysfunctions

  A French validated questionnaire (no name) fomr Moreddu at el. (2017) will be used to assess salivary dyfunctions. The questions concerned discomfort, pain, hyposialorrhoea, and quality of life. Nine of the 13 questions use nominal variables (Yes/No), and two use ordinal variables. A visual analogue scale (VAS) is also included into the questionnaire to evaluate the intensity of pain (greater score for higher pain, from 0 to 10). The outcome 5 will be determined with at least 1 "yes" to a nominal question or a score \>7 at the VAS.

  18 months

• Nutrition

  The EVA (échelle visuelle analogique) will be used to asses a decrease in nutrition with a score between 0 and 10. A score less than 8 will determine troubles in nutrition.

  18 months

Study Arms (2)

patients treated by 1.1 GBq

Drug: Radioiodine

patients treated by 3.7 GBq

Drug: Radioiodine

Interventions

Radioiodine DRUG

cancer therapy

patients treated by 1.1 GBq; patients treated by 3.7 GBq

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all

You may qualify if:

• treated for differencied thyroid cancer
• aged of 18 and more

You may not qualify if:

• having been treated by chemiotherapy or radiotherapy
• no French language
• can't be follow at 6 months after treatment

Sponsors & Collaborators

• Institut de Radioprotection et de Surete Nucleaire: lead

Study Sites (1)

Pitié-Salpêtrière hospital

Paris, 75013, France

Location

Related Publications (2)

• Baudin C, Bressand A, Buffet C, Menegaux F, Soret M, Le AT, Cardon T, Broggio D, Bassinet C, Huet C, Armengol G, Richardson DB, Leenhardt L, Bernier MO, Lussey-Lepoutre C. Dysfunction of the Salivary and Lacrimal Glands After Radioiodine Therapy for Thyroid Cancer: Results of the START Study After 6-Months of Follow-Up. Thyroid. 2023 Sep;33(9):1100-1109. doi: 10.1089/thy.2023.0090. Epub 2023 Jun 23.

  PMID: 37300484 DERIVED

• Baudin C, Lussey-Lepoutre C, Bressand A, Buffet C, Menegaux F, Soret M, Broggio D, Bassinet C, Huet C, Armengol G, Leenhardt L, Bernier MO. Salivary Dysfunctions and Consequences After Radioiodine Treatment for Thyroid Cancer: Protocol for a Self-Controlled Study (START Study). JMIR Res Protoc. 2022 Jul 22;11(7):e35565. doi: 10.2196/35565.

  PMID: 35867385 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

saliva samples

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Iodine-131

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 6, 2021
• Study Start: September 2, 2020
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)