AzTrials
AzTrials

Thyroid CancerSTARTNCT04876287

Salivary dysfuncTion After Radioiodine Treatment

An observational study of Thyroid Cancer, run by French Nuclear Safety and Radiation Protection Authority (ASNR) at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
Radioiodine
How many people
138 participants
Where
1 siteFrance
Study dates
2 Sep 2020to 26 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: all

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Pitié-Salpêtrière hospital

    Paris, 75013

Other trials in France

About this study

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.

Read more

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
Being tested
Radioiodine
Keywords
radioiodine, salivary dysfunctions, genetic polymorphism, dosimetry
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadioiodineDrug

    cancer therapy

Study groups in NCT04876287
Study groupRoleWhat they receive
patients treated by 1.1 GBqNot described
Receives: Drug: Radioiodine
patients treated by 3.7 GBqNot described
Receives: Drug: Radioiodine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. 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.

    Measured: 18 months

  3. 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.

    Measured: 18 months

  4. 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.

    Measured: 18 months

  5. 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.

    Measured: 18 months

  6. 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.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start2 Sep 2020
  3. Primary completion26 Apr 2021
  4. Study completion26 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04876287
Sponsor's protocol ID
2020-A00208-31
Acronym
START
Status last verified
May 2021
First submitted
26 Apr 2021
Last updated
10 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37300484

  • 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.

    PubMed 35867385

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Cancer, run by French Nuclear Safety and Radiation Protection Authority (ASNR) at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

decrease in salivary flow (mL) after radioiodine therapy (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04876287, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in