CBD for Breast Cancer Primary Tumors
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
This is a randomized placebo controlled partially blinded window of opportunity trial. A maximum of 84 patients with invasive breast cancer will be enrolled. Patients will be randomized 2:2:1:1 to either CBD low dose, CBD high dose, matching low dose placebo, or matching high dose placebo using permuted block randomization with random block sizes of 6 or 12. The time window between CBD or placebo initiation and surgery will be between 5 and 56 days.
Eligibility criteria
Qualifiers
Patients who are able to consent for surgery.
Histologically confirmed invasive breast cancer (stages I, II, or III) with Ki67 proliferation rate greater than or equal to 10%.
Women 18 years of age or older at time of consent.
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.
Disqualifiers
Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy.
Known allergy to sesame. Please note the study product contains sesame oil.
South Carolina State employees or anyone whose work requires THC drug testing.
Patients taking drugs metabolized by cytochrome p450 including warfarin, amiodarone, levothyroxine, clobazam, lamotrigine, valproate, prednisolone, hydrocortisone, clarithromycin, itraconazole, erythromycin, fluconazole, clopidogrel, rifampin, sulfamethoxazole, any opioids, and antiepileptic medications including carbamazapine, phenytoin, and valproic acid.
Trial design
Treatments tested in this trial
- CBD Oral
- Control
Treatment groups
84 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov