NCT00604318

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

4 years

First QC Date

January 17, 2008

Last Update Submit

January 9, 2013

Conditions

Thyroid Cancer

Keywords

quality of life

Outcome Measures

Primary Outcomes (1)

  • quality of life

    month

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Drug: rhTSH

rh-TSH

ACTIVE COMPARATOR

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

Drug: rhTSH

Interventions

rhTSHDRUG

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

Also known as: Thyrogen - GEnzyme
placeborh-TSH

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Follicular or papillary thyroid cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Oncology, Herlev Hospital

Herlev, Herlev, dk- 2730, Denmark

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Thyrotropin Alfa

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

ThyrotropinPituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Birte Nygaard, Md, PhD

    dept of endocrinology,Herlev Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2008

First Posted

January 30, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

DK(1)