Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT00873366
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Eligible to receive tamoxifen for 6 months for either the prevention or treatment of non-invasive or invasive, stage I-III breast cancer
* CYP2D6 genotype known
* Patients determined to be CYP2D6 poor metabolizers (by determination of a genotype test by their Mayo physician prior to study registration) are eligible to proceed with the initial breath test only
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* ECOG performance status 0-2
* Life expectancy \> 6 months
* No known impaired hepatic activity defined as ≥ grade 3 AST, alkaline phosphatase, or total bilirubin
* No pulmonary disease (e.g., asthma or other respiratory disease) associated with hypercapnia
* No uncontrolled metabolic disease (e.g., diabetes in the presence of gastroparesis, uncontrolled congestive heart failure, or uncontrolled gastrointestinal disorders \[e.g., GERD\])
* No prior adverse reaction to dextromethorphan
* No history of chronic liver disease (e.g., hepatitis B or hepatitis C, alcoholic liver disease, cirrhosis, or fibrotic disease)
* Able and willing to fast overnight prior to the study session
* Willing to return to Mayo Clinic for follow-up
* Willing to provide biologic specimens
PRIOR CONCURRENT THERAPY:
* More than 24 hours since prior medications known to slow gastric emptying or gastrointestinal motility (e.g., alcohol, opioid analgesics, anticholinergics \[e.g., antihistamines\], and loperamide)
* More than 4 weeks since prior and no concurrent CYP2D6 inhibitors or concurrent serotonin-reuptake inhibitors known to be potent CYP2D6 inhibitors (e.g.,paroxetine \[Paxil®\] and fluoxetine \[Prozac®\]
* If mild to moderate inhibitors of CYP2D6 are medically necessary, patients may go back on after the 8-week time point
* More than 4 weeks since prior and no concurrent monoamine-oxidase inhibitors (e.g., furazolidone, phenelzine, procarbazine, selegiline, and tranylcypromine)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00873366
Study Brief:
Protocol Section:
NCT00873366