Salivary dysfuncTion After Radioiodine Treatment

Thyroid Cancer Clinical Trial

— START  

Official title:

Salivary dysfuncTion After Radioiodine Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04876287
• Other study ID #: 2020-A00208-31
• Status: Completed
• Start date: September 2, 2020
• Est. completion date: April 26, 2021

Study information

• Verified date: May 2021
• Source: Institut de Radioprotection et de Surete Nucleaire
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: April 26, 2021
• Est. primary completion date: April 26, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• treated for differencied thyroid cancer

• aged of 18 and more

Exclusion Criteria:

• having been treated by chemiotherapy or radiotherapy

• no French language

• can't be follow at 6 months after treatment

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Neoplasms

Intervention

Drug:
• Radioiodine
cancer therapy

Locations

Country	Name	City	State
France	Pitié-Salpêtrière hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Radioprotection et de Surete Nucleaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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