Early Phase 1 Peripheral Neuropathy 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 have colorectal cancer that has spread or cannot be surgically removed, and who are planned to receive a chemotherapy treatment containing oxaliplatin for at least 3 months.
• People who have had no more than one cycle of oxaliplatin-based chemotherapy before enrolling.
• People whose general health and ability to function falls within a certain range — specifically, rated 0, 1, or 2 on a standard medical performance scale (confirm with trial site).
• People who have never previously been treated with platinum-based chemotherapy drugs.
• People who have no signs of nerve damage (neuropathy) at the time of enrollment.
• People whose bone marrow and organ function are considered suitable for chemotherapy by their doctor, including liver test results that fall within specific acceptable ranges.
• People who are able to understand the study and are willing to sign a consent form agreeing to participate.

Who may not be able to join:

• People who have a personal or family history of inherited nerve disease, any ongoing nerve damage, nervous system conditions that could affect thinking (such as Parkinson's disease or multiple sclerosis).
• People who have used recreational marijuana more than 4 times per month, or have used illicit drugs in the past 90 days. People using medical cannabis products would need to have stopped at least one week before enrollment.
• People with a known serious liver disease or liver test results outside the acceptable range at screening.
• People who have untreated cancer that has spread to the brain, or who have had brain metastases treated but are currently taking anti-seizure medications.
• People who are currently taking anti-seizure or anti-psychotic medications. People who previously took anti-seizure medications but stopped more than 3 months ago may still be considered. Use of certain antidepressants known as SSRIs is permitted.
• People who are currently taking certain medications that strongly affect how the body processes drugs (specifically, strong inducers of CYP3A4 and CYP2C19 — confirm with trial site).
• People with a history of epilepsy or recurring seizures, or an unexplained seizure within the past 6 months.
• People who have ever been diagnosed with certain mental health conditions including schizophrenia, psychotic disorders, bipolar disorder type I or II, certain personality disorders (antisocial, borderline, narcissistic, or histrionic), or eating disorders.
• People who have a recent history of, or current concern about, severe depression with thoughts of suicide, as assessed by the study doctor.
• People who are currently taking specific medications that are known to interact badly with FDA-approved cannabidiol (Epidiolex), including buprenorphine, clobazam, lamotrigine, valproate, and several others (confirm full list with trial site).
• People who are pregnant or breastfeeding, or people of any sex who are able to have children but are unwilling to use an effective form of birth control during the study.
• People who are currently participating in another clinical trial involving an investigational treatment.

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