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Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02
Plain-language guide to NCT00659373: phase 3 randomized trial of Triptorelin, 86 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00659373
- Phase
- phase 3
- Status
- completed
- Start
- 2007-12
- Completion (planned or actual)
- 2014-12
- Participants
- 86 (actual)
- Design
- randomized, open label (everyone knows who gets what)
- Conditions studied
- Breast Cancer; Fatigue; Sleep Disorders
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Triptorelin.
It had three arms (groups): Tamoxifen (active comparator), T+OFS (experimental) and E+OFS (experimental).
The registry classes the interventions as drug.
More on the Plan
OUTLINE: This is a multicenter study.
Objective cognitive function was measured with the CogState computerized test battery.
Performance speed is measured for the Detection, Identification and Monitoring tasks and performance accuracy is measured for the Memory, Learning, ISLT, and ISLT-Delayed Recall.
Measures of performance speed are normalized using measures of performance accuracy (%) are normalized using arcsine transformation.
Who Took Part
The registry lists 86 actual participants took part.
It was open to women only aged up to 120 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Completely resected disease. Tamoxifen, exemestane, or gonadotropin-releasing hormone (GnRH) agonist. Hormone receptor status:. Estrogen and/or progesterone receptor positive. Each tumor must be hormone receptor positive.
The full record lists 13 inclusion and 0 exclusion criteria.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this Triptorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Triptorelin group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Triptorelin study: the participants and staff both knew the treatment.
It started in 2007-12 with completion listed for 2014-12.
It ran at 15 sites in United States (13) and Canada (2).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Triptorelin in 86 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Triptorelin compound page, all human trials.
Our Notes on the Compound
Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.