NL-OMON21997
Completed
N/A
Study on the possible pharmacokinetic interaction between green tea supplements and tamoxifen in patients with breast cancer.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC
- Enrollment
- 14
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \= 18 years
- •2\. Patients with a confirmed diagnosis of primary or advanced breast cancer, who are on tamoxifen treatment for at least three months (steady state concentration).
- •3\. WHO performance \= 1 (see Appendix B)
- •4\. Able and willing to sign the informed consent form prior to screening evaluations
- •5\. Willing to abstain from strong CYP3A4, CYP2D6, CYP2C9/2C19, UGT and P\-gp inhibitors or inducers, herbal or dietary supplements or other over\-the\-counter medication besides paracetamol. (see Appendix C)
- •6\. Willing to abstain from a cup of green tea (\<4 h after tamoxifen intake)
Exclusion Criteria
- •1\. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria)
- •2\. Patients with an active gastric ulcer
- •3\. Patients with a BMI \>35 kg/m2
- •4\. Age \>80 years
- •5\. Known serious illness or medical unstable conditions that could interfere with this study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or herpes zoster, organ transplants, kidney failure (GFR\<30 ml/min/1\.73 m2\), serious liver disease (e.g. severe cirrhosis), cardiac and respiratory diseases)
- •6\. A CYP2D6 poor metabolizer or ultra\-rapid metabolizer phenotype based on CYP2D6 genotyping outcome
- •7\. Use of strong CYP3A4, CYP2D6, CYP2C9/2C19, UGT and P\-gp inhibitors or inducers , herbal or dietary supplements or other over\-the\-counter medication besides paracetamol (e.g. Veregen, grapefruit, st. Johns\-wort)
Outcomes
Primary Outcomes
Not specified
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