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Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Treatment

Active

18 to 75

Other

Dathyrca 1
EudrCT 2007-002713-39, HB-2007-043, Data register 2007-41-120, NCT00604318

Trial Description

Summary

To evaluate quality of life in patients after 10 days pause of thyroid medication (Liothyronine) compared to treatment with recombinant TSH (Thyrogen) before radioiodine uptake and treatment in a double-blinded, randomised cross-over design.

Further Study Information

Patients with a thyroid follicular or papillary cancer referred to radioiodine treatment in oncological department . The patients after thyroidectomy will be treated with Liothyronine and this treatment will be paused 10 days before radioiodine. As a routine these patients will be re-evaluated with iodine uptake 4 months later.

The patients will be randomised to either T3 pause related to the first radioiodine treatment and Thyrogen injection (recombinant TSH) related to the second treatment/uptake - or Thyrogen related to the first treatment and T3 pause related to the second treatment /uptake.

All medication given in the 10 days period right before radioiodine treatment/uptake will be delivered to the patients and marked with a protocol number. In the period with T3 pause the patients will be given placebo tablets and an injection of saline (instead of Thyrogen) before treatment/uptake at the similar time as given the Thyrogen injection. A nurse otherwise not involved in the study will give the injection.

Patients will be evaluated by VAS, SF-36, and Eortc QLC30 (version 2.0) before radioiodine treatment and 3 weeks after treatment.

Eligibility Criteria

Inclusion Criteria:

Follicular or papillary thyroid cancer

Exclusion Criteria:

< 18 or > 75 years old

Pregnant or lactating women

Trial Contact Information

Trial Lead Organizations/Sponsors

Copenhagen County Herlev University Hospital

Odense University Hospital

Birte Nygaard, Md, PhD

Study Chair

Birte Nygaard, Md, PhD		Ph: +45 44883655
		Email: binyg@heh.region h.dk

Jens Bentzen
		Email: jeben@heh.regionh.dk

Trial Sites

Denmark

Herlev

Copenhagen County Herlev University Hospital

Jens Bentzen, Md

Email: jeben@heh.regionh.dk

Jens Bentzen, MD Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00604318
Information obtained from ClinicalTrials.gov on September 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.