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Studying the influence of curcumin and piperine on tamoxifen exposure

Completed
Conditions
Breast cancer
Registration Number
NL-OMON25193
Lead Sponsor
Erasmus MC
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
16
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Age > 18 years

Exclusion Criteria

A potential subject who meets any of the following criteria before study treatment will be excluded from participation in this study:

1. Pregnant or lactating patients.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To determine the influence of curcumin with or without piperine, in patients with breast cancer, on endoxifen plasma pharmacokinetics (AUC).
Secondary Outcome Measures
NameTimeMethod
1. Other pharmacokinetic outcomes (i.e. clearance, Ctrough) and the tamoxifen/endoxifen ratio.<br /><br>2. To evaluate plasma concentration levels of tamoxifen and other tamoxifen metabolites<br /><br>3. To evaluate the incidence and severity of side-effects of treatment with tamoxifen in absence and presence of curcumin with or without piperine.
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