borstkanker breast cancer
Conditions
Interventions
Determination of CYP2D6 clinical phenotype by 13C-dextrometorphan breath test
and using 50 mg 13C-dextromethorphan as a phenotyping probe.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women who have been diagnosed with HR+ LBC MBC (presence of at least 1 visceral metastasis) and are currently on tamoxifen therapy for at least two months.
Exclusion criteria
Exclusion criteria: *Presence of infectious disease *Treatment with chemotherapy, in the last 4 weeks *Treatment with CYP2D6 inhibiting medication in last 2 weeks *Treatment with CYP2D6 inducing medication in the last 4 weeks *Treatment with MAO-inhibitors in the last 2 weeks *Treatment with medications, which slow gastro-intestinal medication in the last 24 hours *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 13C-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 dextromethorfan exposure. *Impaired hepatic function as defined by * Grade 3 AST, alkaline phosphatase or total bilirubin or a history of liver cirrhosis *Renal insufficiency *Use of dextromethorfan cough syrup/tablets within 24 hours of the breath test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parameters concerning CYP2D6 clinical phenotype which are collected:: - DOB values on t=0-120 - AUCDOB0-120 - Cumulative percentage of dose recovery (cPDR) Serum endoxifen levels | — |
Secondary
| Measure | Time frame |
|---|---|
| -liver and renal function -parameters probably associated with metabolism will be collected: -interleukine-6, TNF-alfa, albumin | — |
Countries
Netherlands
Outcome results
None listed