breast cancer
Conditions
Interventions
Patients included in the amendment will be given 50 mg 13-C dextromethorphan,
prior to the breath test. Subjects are asked to breath in a plastic bag for 11
times during each breath test.
One sample
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Pre- and postmenopausal women who have already been using tamoxifen as part of a standard adjuvant therapy for newly diagnosed breast cancer;2. Willing and able to give written informed consent ;3. Age >= 18 years;4. Women who have already been enrolled in the first amendment on the CYPTAM documentation study ((P.07.234): Addition of CYP2D6 phenotyping by a 13C-dextrometorphan breath test (DM-BT)) and are currently on tamoxifen therapy for at least two months.
Exclusion criteria
Exclusion criteria: Inability or unwillingness to fast overnight prior to the study session. Inability or willingness to abstain from drinking alcohol for 24 h prior to the DM-BT. A diagnosis of pulmonary disease such as asthma or other respiratory disease associated with hypercapnia. Existence of metabolic or gastrointestinal disorders which influence absorption and/or gastric emptying. A demonstrated adverse reaction to previous dextromethorphan exposure. Impaired hepatic function as defined by >= Grade 3 AST, alkaline phosphatase or total bilirubin or a history of liver chirrosis Renal insufficiency Use of medication known to slow gastric emptying or gastrointestinal motility within 24 hours of the breath test (known to slow gastric emptying or gastrointestinal motility • The use of MAO inhibitors in the last two weeks Use of dextrometorphan cough syrup/tablets within 24 hours of the breath test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between CYP2D6 phenotype (by 13C-dextromethorphan breath test) and endoxifen serum levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| none | — |
Countries
Netherlands
Outcome results
None listed