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

Completed

Conditions: breastcancer
Primary hormone sensitive breast cancer
10006291

Registration Number: NL-OMON52942

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 26

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
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.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoint is the Area Under the plasma concentration time<br /><br>Curve (AUC0-24h) of endoxifen.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are pharmacokinetic parameters of tamoxifen, other<br /><br>pharmacokinetic parameters of endoxifen, toxicity of tamoxifen measured by<br /><br>Quality of Life questionnaires (EORTC-QLQ-BR23; FACT-B/FACT-ES), potential<br /><br>toxicity of CBD based on the CTCAE version 5.0 and the AUC0-24h of CBD.</p><br>