Breast Cancer
Conditions
Interventions
CBD oil: 5 drops 10% CBD three times daily sublingually for 28 consecutive days. Five drops 10% CBD is equivalent to 18 mg CBD.
Sponsors
Erasmus MC and CCC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. WHO performance = 1 (appendix B) 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 selfcare 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
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is the Area Under the plasma concentration time Curve (AUC0-24h) of endoxifen | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are pharmacokinetic parameters of tamoxifen, other pharmacokinetic parameters of endoxifen, toxicity of tamoxifen measured by Quality of Life questionnaires (EORTC-QLQ-BR23; FACT-B), potential toxicity of CBD based on the CTCAE version 5.0 and the AUC0-24h of CBD | — |
Contacts
Public ContactCornelis Louwrens Braal
Erasmus MC Cancer Institute
Outcome results
None listed