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Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and Tolerance

Primary Purpose

Graves Disease (Basedow's Disease)

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation
The initiation of LT4 as soon as the first biological signs of hypothyroidism.
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graves Disease (Basedow's Disease)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient presenting a hyperthyroïdie Basedowienne proving a treatment by iodine 131.

    • Patient without or with ophtalmopathie junior defined by a score of ophtalmopathie in 0 or in 1 and a score of clinical activity in 0 (see secondary).
    • Patient whose rate of fT4 and\or of fT3 is lower than 1,5 times the superior limit of the standards of the laboratory during the balance sheet(assessment) which precedes the treatment by iodine 131 (15j.
    • Patient whose thyroïdien volume estimated by echography is lower than 60 mL.
    • Patient whose treatment by anti-thyroïdiens of synthesis was interrupted at least 5 days before the administration of iodine 131.
    • 18 years old male or feminine Patient or more.

Exclusion Criteria:

  • Patient presenting a thyroïdien nodule suspect of wickedness.

    • Patient presenting disorders not thyroïdiens known to distort the fixation of I131 (congestive heart failure of class III or IV, renal insufficiency).
    • Patient having received by intravenous way a product of hydrosoluble contrast for radiography in 4 weeks preceding the randomization, or by way intra-thécale or for cholécystographie by a product of contrast iodized in three months preceding the randomization.
    • Patient taking medicines susceptible to disrupt the function thyroïdienne or renal (renal medicines, lithium, amiodarone, in particular).
    • Patient presenting a contraindication to Levothyroxine with high dose: décompensée heart disorder, coronaropathie, shady of the unchecked rhythm.
    • pregnant or breast-feeding Women, or patient being able to have children and refusing to follow a reliable contraceptive method during the duration of the study.

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

conventional approach

experimental approach

Arm Description

conventional traitment

early and systematic traitment

Outcomes

Primary Outcome Measures

will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO).

Secondary Outcome Measures

compare quality of life outcomes at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck), autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy and medico-economic data.

Full Information

First Posted
January 27, 2011
Last Updated
April 20, 2015
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01295333
Brief Title
Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and Tolerance
Official Title
Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and Tolerance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of our study is to compare in a randomized multicentric study the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation (experimental arm) compared to a conventional approach based on the initiation of LT4 as soon as the first biological signs of hypothyroidism. Two hundred patients with Graves' disease with no or minimal (eyelid retraction or oculopalpebral asynergy) and non inflammatory ophthalmopathy (clinical activity score to 0) will be included in this study. The administrated iodine-131 activity will be adjusted to the weight of the thyroid gland (20 MBq/g thyroid tissue). Patients will be evaluated at 6 weeks, 3 months, 6 months and 12 months post-ablation. The primary objective will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO). Secondary objectives will compare quality of life outcomes at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck), autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy and medico-economic data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Disease (Basedow's Disease)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional approach
Arm Type
Other
Arm Description
conventional traitment
Arm Title
experimental approach
Arm Type
Experimental
Arm Description
early and systematic traitment
Intervention Type
Drug
Intervention Name(s)
the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation
Intervention Type
Drug
Intervention Name(s)
The initiation of LT4 as soon as the first biological signs of hypothyroidism.
Primary Outcome Measure Information:
Title
will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
compare quality of life outcomes at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck), autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy and medico-economic data.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient presenting a hyperthyroïdie Basedowienne proving a treatment by iodine 131. Patient without or with ophtalmopathie junior defined by a score of ophtalmopathie in 0 or in 1 and a score of clinical activity in 0 (see secondary). Patient whose rate of fT4 and\or of fT3 is lower than 1,5 times the superior limit of the standards of the laboratory during the balance sheet(assessment) which precedes the treatment by iodine 131 (15j. Patient whose thyroïdien volume estimated by echography is lower than 60 mL. Patient whose treatment by anti-thyroïdiens of synthesis was interrupted at least 5 days before the administration of iodine 131. 18 years old male or feminine Patient or more. Exclusion Criteria: Patient presenting a thyroïdien nodule suspect of wickedness. Patient presenting disorders not thyroïdiens known to distort the fixation of I131 (congestive heart failure of class III or IV, renal insufficiency). Patient having received by intravenous way a product of hydrosoluble contrast for radiography in 4 weeks preceding the randomization, or by way intra-thécale or for cholécystographie by a product of contrast iodized in three months preceding the randomization. Patient taking medicines susceptible to disrupt the function thyroïdienne or renal (renal medicines, lithium, amiodarone, in particular). Patient presenting a contraindication to Levothyroxine with high dose: décompensée heart disorder, coronaropathie, shady of the unchecked rhythm. pregnant or breast-feeding Women, or patient being able to have children and refusing to follow a reliable contraceptive method during the duration of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Learn more about this trial

Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and Tolerance

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