Status:
NOT_YET_RECRUITING
CBD for Breast Cancer Primary Tumors
Lead Sponsor:
Medical University of South Carolina
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a randomized placebo controlled double blind window of opportunity trial. A maximum of 120 patients will be enrolled. Up to 60 patients with invasive breast cancer will be enrolled into cohort...
Eligibility Criteria
Inclusion
- 1\. Histologically confirmed invasive breast cancer (stages I, II, or III) or DCIS with primary tumor(s) ≥ 0.8 cm on mammogram, ultrasound, MRI, or physical exam 2.18 years of age or older 3.Subject must understand risks and benefits of the protocol and be able to give informed consent 4.Women of child-bearing potential (WOCBP) must agree to use an approved form of birth control and to have a negative pregnancy test result before registration. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes.
- 5\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6.Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to registration:
- ANC ≥ 1.5 × 109/L
- Platelet count ≥ 100 × 109/L
- Hemoglobin ≥ 9 g/dL
- Albumin ≥ 2.5 g/dL
- Bilirubin ≤ 1.5 × the upper limit of normal (ULN)
- AST, ALT, and alkaline phosphatase ≤ 3 × ULN
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 40 mL/min on the basis of measured CrCl from a 24-hour urine collection or Cockcroft-Gault\* glomerular filtration rate estimation:
- (140-age) × (weight in kg) × (0.85 if female) 72 × (serum creatinine in mg/dL)
- \* The Modification of Diet in Renal Disease (Levey et al. 2006) and the Chronic Kidney Disease Epidemiology Collaboration (Levey et al. 2009) formulas for estimation of glomerular filtration rate are also acceptable.
- 7\. Ability and capacity to comply with the study and follow-up procedures 8. Subjects must be scheduled for surgery no less than 5 days from the planned start of day 1 and no more than 56 days from the planned start of day 1.
- 9\. If patients are taking home regimens of CBD or marijuana, they must consent to abstain for the length of the trial.
Exclusion
- Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy
- Subjects who are pregnant or are lactating.
- Patients taking drugs metabolized by cytochrome p450 (warfarin, amiodarone, levothyroxine, clobazam, lamotrigine, valproate, prednisolone, hydrocortisone, clarithromycin, itraconazole, erythromycin, fluconazole, clopidogrel, rifampin, sulfamethoxazole, any opioids, antiepileptic medications (including carbamazapine, phenytoin, valproic acid, but excepting of gabapentin, clonazepam, or diazepam).
- Routine use of recreational or medicinal marijuana products (defined as \> 4 times per month) or illicit drug use including opioids, cocaine, amphetamines, PCP, LSD
- Concurrent use of over-the-counter CBD oil, Marinol®, Delta-8 THC, or cannabis
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CBD or placebo
- Underlying history of epilepsy/ recurrent seizure disorder or unexplained seizure within past 6 months
- Patients with uncontrolled cardiovascular disease defined by myocardial infarction, stroke, or transient ischemic attack, or need for coronary stent placement within past six months.
- Patients with a psychiatric illness or psychiatric symptoms that would prevent them from completing study procedures or would disqualify them from surgical intervention (e.g., untreated schizophrenia, bipolar disorder, or suicide ideation/attempt resulting in psychiatric hospitalization within the last 30 days).
- Women who are pregnant or breastfeeding or who refuse to practice an effective form of birth control (condoms, diaphragm, birth control pill, IUD)
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06148038
Start Date
March 1 2026
End Date
January 1 2028
Last Update
April 8 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.