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

Copenhagen University Hospital at Herlev

Status and phase: Completed; Phase 4

Conditions: Thyroid Cancer

Treatments: Drug: rhTSH

Study type: Interventional

Funder types: Other

Identifiers

NCT00604318

HB-2007-043 (Registry Identifier)

2007-002713-39 (EudraCT Number)

Dathyrca 1

Data register 2007-41-120 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Follicular or papillary thyroid cancer

Exclusion criteria

• < 18 or > 75 years old
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

To receive the placebo treatment in connection with the primary RI therapy and the T3 tablets and rh-TSH injections prior to second RI uptake measurement

Treatment:

Drug: rhTSH

rh-TSH

Active Comparator group

Description:

To continue with L-T3 and to receive rh-TSH stimulation with 0,9 mg Thyrogen® (Genzyme) x 2 days minus 1 and 2 prior to RI therapy, and following this to have placebo tablets and placebo injections with isotone NaCl prior to the RI uptake measurement 4-6 months later

Treatment:

Drug: rhTSH