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van CCT (UK)

van CCT (UK)

Studying the influence of curcumin and piperine on tamoxifen exposure

- candidate number26486
- NTR NumberNTR6149
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jan-2017
- Secondary IDsMEC 16-679 METC Erasmus MC
- Public TitleStudying the influence of curcumin and piperine on tamoxifen exposure
- Scientific TitleThe effects of curcumin and piperine on the pharmacokinetics of tamoxifen in patients with breast cancer ¡®the ELDORADO study¡¯
- hypothesisTo determine the influence of curcumin and piperine on tamoxifen pharmacokinetics.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteriaIn 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 criteriaA 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 30-jan-2017
- planned closingdate30-jan-2018
- Target number of participants16
- InterventionsTamoxifen alone vs Tamoxifen and Curcumin vs Tamoxifen and Curcumin and Piperine
- Primary outcomeTo determine the influence of curcumin with or without piperine, in patients with breast cancer, on endoxifen plasma pharmacokinetics (AUC).
- Secondary outcome1. 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.
- TimepointsPharmacokinetics will be taken at day 28, 56 and 84.
- Trial web site
- statusinclusion stopped: follow-up
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Rotterdam
- Publications
- Brief summaryIn 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)
- RECORD16-jan-2017 - 20-aug-2018

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