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ISRCTN
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ISRCTN27681212
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ClinicalTrials.gov identifier
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Public title
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Well being of patients with thyrotoxicosis after radioactive iodine treatment using block and replace compared to titrated regime
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0203173366
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Study hypothesis
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To assess whether the quality of life and well-being at 6 weeks, 6 months & 12 months using SF36-II and GHQ-12 (General Health Questionnaire) after radioactive iodine treatment for thyrotoxicosis is better with block & replacement regime compared to traditional titrating regime.
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Ethics approval
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Not provided at time of registration
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Study design
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Radioactive iodine
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Nutritional, Metabolic, Endocrine: Hyperthyroidism
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Participants - inclusion criteria
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According to the current local practice, patients needing radioactive iodine treatment will be seen by our Endocrine Specialist Nurses. These patients will be assessed for their eligibility for this study. If the patients are eligible, they will be given the information sheet about the study. If they are happy to take part, before the radioactive iodine treatment, written consent will be obtained and patients will be randomised at that stage.
Inclusion Criteria:
1. Toxic nodular thyroid disease (toxic multinodular goitre or toxic nodule)
2. Garves' thyrotoxicosis with patients' preference to have RAI
3. Recurrent Graves' thyrotoxicosis
4. Age between 18 and 80 years.
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Participants - exclusion criteria
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1. Pregnant or lactating women
2. Patients allergic to antithyroid drugs or iodine
3. Active thyroid eye disease
4. Known alcohol or drug abuse
5. Significant psychiatric disturbances
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Anticipated start date
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13/09/2005
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Anticipated end date
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31/12/2008
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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140
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Interventions
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All the patients identified as suitable for radioactive iodine treatment will be referred to the endocrine specialist nurse as per the routine practice. The patients will then be screened for the inclusion and exclusion criteria. Eligible patients will then be sent / given written information about the study. Interested patients will come for their first visit to see the endocrine specialist nurse. After obtaining written informed consent, patients will be randomised to either the block & replace group or the titrated regime group. Six weeks after having the radioactive iodine treatment, patients will be seen by the endocrine specialist nurse for their second study visit. They will then follow the treatment algorithm. Third evaluation of patients is done at 6 months and the final evaluation is done at 12 months.
At each visit patient will be asked to fill up 3 questionnaires (SF36-II, GHQ-12 & TSQ). In addition they will fill up one question on satisfaction to treatment question. They will also have blood tests for their thyroid function. The blood test is part on the routine care and is not an additional test for the study.
User involvement: We will invite 1 or 2 thyrotoxicosis patients who has already under went radioactive iodine treatment to comment on the patient information sheets. We would also be giving regular feedback to the patients during and at the end of the study.
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Primary outcome measure(s)
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Differences in the scores on SF36-II & GHQ-12 between the 2 groups at 6 weeks, 6 months and 12 months, controlling for the baseline scores
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Royal Devon and Exeter NHS Trust
Royal Devon & Exeter NHS Foundation Trust
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Dr
Ponnusamy
Saravanan
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Address
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Royal Devon & Exeter Hospital (Wonford)
Barrack Road
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City/town
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Exeter
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Zip/Postcode
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EX2 5DW
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Country
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United Kingdom
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Tel
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+44 01392 402 281
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Fax
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+44 01392 402 270
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Email
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Ponnusamy.Saravanan@rdehc-tr.swest.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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29/09/2006
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Date ISRCTN assigned
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29/09/2006
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