NL-OMON52942
Completed
N/A
Study on the potential pharmacokinetic interaction between cannabidiol (CBD) and tamoxifen in patients with primary breast cancer - The TUCAN study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 26
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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