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

Study Timeline

• Last Update Posted: 28 February 2024

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

Name	Time	Method
To determine the influence of curcumin with or without piperine, in patients with breast cancer, on endoxifen plasma pharmacokinetics (AUC).

Secondary Outcome Measures

Name	Time	Method
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.