Study on the potential pharmacokinetic interaction between cannabidiol (CBD) and tamoxifen in patients with primary breast cancer - The TUCAN study

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 26 人开始时间: 待定最近更新: 2024年4月15日

试验速览

暂无简介。

•1. Age >= 18 years
•2. WHO performance <= 1
•3. Patients with primary breast cancer, who are on adjuvant tamoxifen treatment
•and are willing to be treated with tamoxifen for at least 2 more months
•4. Patients need to be on a steady state endoxifen level of at least 16 nmol/l
•5. Patients need to experience at least one of the following tamoxifen-related
•side effects (based on the CTCAE version 5.0)
•a. Hot flashes: at least >10 hot flashes during 24 hours and moderate (limited
•instrumental ADL) or severe (limited self-care ADL)
•b. Insomnia: difficulty falling asleep, staying asleep or waking up early
•c. Arthralgia: moderate (i.e. limited instrumental ADL) or severe (i.e. limited
•self-care ADL)
•d. Mood alterations: moderate or severe, as distinguished by CTCAE version 5.0.
•6. Able and willing to sign the informed consent form prior to screening
•evaluations
•7. 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.

•1. Patients with known impaired drug absorption (e.g. gastrectomy and
•achlorhydria)
•2. 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<30 ml/min/1.73 m2),
•serious liver disease (e.g. severe cirrhosis), cardiac and respiratory diseases)
•3. Use of cannabinoids in the last 3 months.

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