|- candidate number||14669|
|- NTR Number||NTR3933|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-apr-2013|
|- Secondary IDs||NL41880.041.13 / 13-080 CCMO / METC|
|- Public Title||Shortened treatment strategy in patients with differentiated thyroid cancer.|
|- Scientific Title||Fast-track thyroidectomy and radioiodine ablation therapy in patients with differentiated thyroid cancer.|
|- hypothesis||By reducing the interval between thyroidectomy and radioiodine ablation therapy in patients sick leave time of the patients can be reduced and the quality of life improved. Furhermore costs will for society will be lower.|
|- Healt Condition(s) or Problem(s) studied||Differentiated thyroid carcinoma|
|- Inclusion criteria||1. Patients with proven differentiated thyroid cancer, stage T1-3N0-1M0;|
2. Planned for total or completion thyroidectomy;
3. Paid job; at least 12 hours per week;
4. Capable of understanding Dutch questionnaires and keeping a diary.
|- Exclusion criteria||1. Pregnant or breastfeeding patients;|
2. T4 (i.e. tumor expansion in vital structures) or M1 tumors;
3. Contrast enhanced CT performed < 4 months prior to inclusion;
4. Hypersensitivity to bovine serum albumin, rhTSH or to any of the excipients;
5. Dialysis-dependent end stage renal disease.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2013|
|- planned closingdate||1-nov-2015|
|- Target number of participants||58|
|- Interventions||Standard treatment: Thyroidectomy followed by a 4-6 week during waiting period and then ablation with radioactive iodine.
Interventional treatment: Thyroidectomy directly followed by radioactive iodine ablation.
|- Primary outcome||Days of sick leave reported from time of surgery.|
|- Secondary outcome||1. Quality of life;|
2. Costs associated with productivity at work;
3. Societal costs associated with absence from work.
|- Timepoints||Continuous monitoring of sick leave and quality of life from start of treatment until 2 months after therapy.|
|- Trial web site||www.fasthyna.nl|
|- CONTACT FOR PUBLIC QUERIES||Drs. J.W. Kist|
|- CONTACT for SCIENTIFIC QUERIES||Drs. J.W. Kist|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU)|
|- Brief summary|| The initial treatment of patients with differentiated thyroid cancer (DTC) consists of total thyroidectomy followed by thyroid remnant radioiodine ablative therapy (RIT). For successful RIT, elevated levels of thyroid stimulating hormone (TSH) are required. Before the introduction of recombinant human TSH (rhTSH) patients were withheld thyroid hormone substitution therapy for 4 weeks after surgery. Nowadays RIT after rhTSH admission is possible, preventing thyroid hormone withdrawal and subsequent symptoms of hypothyroidism in these patients. Results of RIT after thyroid hormone withdrawal and rhTSH stimulation are comparable. RIT with rhTSH stimulation allows planning of the RIT shortly after thyroidectomy.
We hypothesize that with the availability of rhTSH the treatment of DTC patients in a fast track protocol, i.e. RIT shortly after thyroidectomy, will reduce sick leave time, which will lead to a cost reduction for society, and secondly that the fast track treatment will lead to a higher quality of life for the patients during treatment. Patients will be sooner ‘back on track’. In this way both society and patients will benefit from the implementation of the fast track protocol.
|- Main changes (audit trail)|
|- RECORD||3-apr-2013 - 29-sep-2013|