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

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Completed

CT.gov ID

NCT01295333

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Graves Disease (Basedow's Disease)	Drug: the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation Drug: The initiation of LT4 as soon as the first biological signs of hypothyroidism.	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2011

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: conventional approach conventional traitment	Drug: The initiation of LT4 as soon as the first biological signs of hypothyroidism.
Experimental: experimental approach early and systematic traitment	Drug: the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation

Arm

Intervention/Treatment

Other: conventional approach

conventional traitment

Drug: The initiation of LT4 as soon as the first biological signs of hypothyroidism.

Experimental: experimental approach

early and systematic traitment

Drug: the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation

Outcome Measures

Primary Outcome Measures

will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO). [2 years]

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. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hopitaux de Marseille	Marseille		France	13354

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: BERNARD BELAIGUES, Assistance Publique hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT01295333

Other Study ID Numbers:

2010-023608-28
2010-23

First Posted:

Feb 14, 2011

Last Update Posted:

Apr 22, 2015

Last Verified:

Apr 1, 2015

Additional relevant MeSH terms:

Graves Disease

Study Results

No Results Posted as of Apr 22, 2015