Study on the possible pharmacokinetic interaction between grean tea supplements and tamoxifen in patients with breast cancer. "the TEA study"

Study on the possible pharmacokinetic interaction between grean tea supplements and tamoxifen in patients with breast cancer. "the TEA study" - TEA study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48342

Enrollment

Registered

2019-08-27

Start date

2019-10-14

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone sensitive breast cancer

Interventions

Fourteen patients on steady-state tamoxifen treatment will be randomised into two different sequences. Depending on which randomization sequence patients will start with tamoxifen alone (sequence AB

Eligibility

Age

18 Years to 99 Years

Inclusion 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 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. 6. Willing to abstain from a cup of green tea (

Exclusion criteria

Exclusion criteria: 1. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria) 2. Patients with an active gastric ulcer 3. 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

Design outcomes

Primary

Measure	Time frame
To compare the Area under the curve (AUC) of endoxifen in patients with breast cancer treated with tamoxifen with and without green tea.	—

Secondary

Measure	Time frame
1. To compare the Area Under the Curve (AUC) of tamoxifen in patients with breast cancer treated with tamoxifen with and without green tea capsules. 2. To compare other tamoxifen and endoxifen pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax), minimal concentration (Ctrough) and time until maximum concentration (Tmax) and elimination half-life (T*)). in patients with breast cancer treated with tamoxifen with and without green tea. 3. To evaluate the incidence and severity of side-effects of treatment with tamoxifen in absence and presence of green tea.	—

Measure

Time frame

1. To compare the Area Under the Curve (AUC) of tamoxifen in patients with breast cancer treated with tamoxifen with and without green tea capsules. 2. To compare other tamoxifen and endoxifen pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax), minimal concentration (Ctrough) and time until maximum concentration (Tmax) and elimination half-life (T*)). in patients with breast cancer treated with tamoxifen with and without green tea. 3. To evaluate the incidence and severity of side-effects of treatment with tamoxifen in absence and presence of green tea.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)