Impact of Daily Oral Cannabis Doses in Patients With Cancer
Trial Parameters
Brief Summary
This study will enroll patients with cancer and participants will be randomized to receive one dose of cannabis for approximately 4 months. There is a 3/4 (or 75%) chance that a participant will receive an active cannabis dose in the study. There is a 1/4 (or 25% chance) that a participant will receive a placebo dose (meaning a blank dose/no cannabis/no active drug). The goals of this study are to determine 1) the safety and tolerability of cannabis in individuals with cancer and 2) if cannabis can help with the side effects of cancer and cancer treatment - including nausea and vomiting, appetite, pain, sleep, and quality of life.
Eligibility Criteria
Example Inclusion Criteria: * Histologically or cytologically confirmed locally advanced or metastatic solid tumors with any types. This applies to either newly diagnosed cancer or preexisting ones on treatment. * Patients with active cancers and currently under any line of treatment (please see notable exceptions in the exclusion criteria - patients taking checkpoint inhibitors and investigational agents will not be eligible - also exclusionary medications). * Patients have been taking their current anti-cancer therapy regimen for at least one month prior to enrollment (to ensure no safety or toxicity issues with study drug initiation). * Age ≥18 years. * ECG and lab values demonstrating adequate organ and marrow function at baseline (pre-study). * Negative urine drug screen for all illicit drugs and THC, CBD prior to randomization * Ability to understand and the willingness to sign a written informed consent document * Individuals able to become pregnant will agree to practice an eff