|- candidate number||26486|
|- NTR Number||NTR6149|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-jan-2017|
|- Secondary IDs||MEC 16-679 METC Erasmus MC|
|- Public Title||Studying the influence of curcumin and piperine on tamoxifen exposure|
|- Scientific Title||The effects of curcumin and piperine on the pharmacokinetics of tamoxifen in patients with breast cancer ¡®the ELDORADO study¡¯|
|- hypothesis||To determine the influence of curcumin and piperine on tamoxifen pharmacokinetics. |
|- Healt Condition(s) or Problem(s) studied||Breast cancer|
|- 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
2. Histological or cytological confirmed diagnosis of breast cancer in patients with an indication for tamoxifen treatment.
3. WHO Performance Status <2
4. Able and willing to sign the Informed Consent Form prior to screening evaluations
5. Abstain from curry, grapefruit (juice), (herbal) dietary supplements besides curcumin, herbals, over-the-counter medication (except for paracetamol and ibuprofen).
6. Adequate baseline patient characteristics (complete blood count, and serum biochemistry which involves sodium, potassium, creatinin, calculation of creatinin clearance (MDRD), AST, ALT, gamma glutamyltranspeptidase (gamma-GT), lactate dehydrogenase (LDH), ALP, total bilirubin, albumin).
|- 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.
2. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria).
3. Use of other drugs, which are mainly dependent for their metabolism on CYP3A4 and CYP2D6.
4. Known serious illness or medical unstable conditions that could interfere with this study; requiring treatment (e.g. infection, bleedings, uncontrolled hypertension despite optimal medical management, HIV, hepatitis, organ transplants, kidney, cardiac and respiratory diseases).
5. Bilirubin CTCAE grade 2 or higher, ASAT/ALAT CTCAE grade 2 or higher and grade 3 or higher in patients with liver metastasis. Renal function impairment CTCAE grade 2 or higher.
6. Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent.
7. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
8. Patients on strong CYP3A4 or CYP2D6 inhibitors or inducers, P-gp substrates or medication or supplements which can interact with tamoxifen and curcumin are not eligible for the study.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||30-jan-2017|
|- planned closingdate||30-jan-2018|
|- Target number of participants||16|
|- Interventions||Tamoxifen alone vs Tamoxifen and Curcumin vs Tamoxifen and Curcumin and Piperine |
|- Primary outcome||To determine the influence of curcumin with or without piperine, in patients with breast cancer, on endoxifen plasma pharmacokinetics (AUC).|
|- Secondary outcome||1. Other pharmacokinetic outcomes (i.e. clearance, Ctrough) and the tamoxifen/endoxifen ratio.|
2. To evaluate plasma concentration levels of tamoxifen and other tamoxifen metabolites
3. To evaluate the incidence and severity of side-effects of treatment with tamoxifen in absence and presence of curcumin with or without piperine.
|- Timepoints||Pharmacokinetics will be taken at day 28, 56 and 84. |
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Koen (G.A.M.) Hussaarts|
|- CONTACT for SCIENTIFIC QUERIES|| Koen (G.A.M.) Hussaarts|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||In this study we try to determine the influence of curcumin with and without piperine on tamoxifen pharmacokinetics in patients with breast cancer. |
|- Main changes (audit trail)|
|- RECORD||16-jan-2017 - 7-feb-2017|