Phase 1 Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to give their own consent for surgery
• People who have been diagnosed with invasive breast cancer (stages I, II, or III) confirmed by a tissue sample, with a tumour growth rate (Ki67) of 10% or higher
• Women aged 18 or older at the time of giving consent
• Women who could potentially become pregnant must agree to use an approved form of contraception and have a negative pregnancy test before joining the trial
• People who are generally well and able to carry out daily activities with little or no limitation (confirmed with trial site)
• People whose recent blood test results show that their blood counts, liver, and kidney function are within acceptable ranges, tested within 14 days before joining
• People who feel they are able to follow the trial procedures and attend follow-up appointments
• People whose surgery is planned to happen between 5 and 56 days after the start of the trial treatment

Who may not be able to join:

• People who are currently receiving chemotherapy or hormone therapy before surgery (neoadjuvant therapy)
• People with a known allergy to sesame, as the study product contains sesame oil
• People who are employees of the State of South Carolina, or anyone whose job requires testing for THC (a cannabis compound)
• People currently taking certain medications that are processed by a specific liver enzyme (cytochrome P450), including warfarin, amiodarone, levothyroxine, clobazam, lamotrigine, valproate, prednisolone, hydrocortisone, clarithromycin, itraconazole, erythromycin, fluconazole, clopidogrel, rifampin, sulfamethoxazole, any opioids, and anti-seizure medications including carbamazepine, phenytoin, and valproic acid
• People who report regularly using marijuana, CBD oil, Marinol®, Delta-8 THC, or cannabis (more than 4 times in the last 30 days), or who use illicit drugs such as cocaine, amphetamines, PCP, or LSD
• People who are currently using over-the-counter CBD oil, Marinol®, Delta-8 THC, or cannabis in any amount
• People who have had an allergic reaction to substances chemically similar to CBD or the placebo used in this trial
• People with a history of epilepsy, recurring seizures, or an unexplained seizure within the past 6 months
• People with uncontrolled heart or blood vessel disease, including a heart attack, stroke, mini-stroke, or coronary stent placement within the past six months
• People with a history of psychiatric illness or symptoms that would prevent them from completing the trial or from being cleared for surgery — for example, untreated schizophrenia, bipolar disorder, or a psychiatric hospitalisation due to suicidal thoughts or attempts within the last 30 days
• Women who are pregnant or breastfeeding
• People currently taking blood-thinning medications such as warfarin, rivaroxaban, clopidogrel, or apixaban

Important: Always verify eligibility with the trial site directly before applying.