A Phase I Study of the Effects of Cannabis on Cancer Burden: Placebo-Controlled, Double-Blind, Randomized Trial
Shanna Babalonis, PhD
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.
Description
Primary Objective: To evaluate the safety and tolerability of daily oral cannabis administration (5 mg THC, 15 mg THC, 15 mg THC+15 mg CBD) relative to placebo in patients with cancer who are on an active anti-cancer therapy. The percent of patients who elect to withdrawal from the study or removed by physician/investigators due AEs or safety concerns in each group will be measured and compared to the placebo group. Secondary Objectives: 1. To evaluate frequency and severity of safety criteria violations from dosing to 4 hrs post-dose (HR, O2 saturation from fitness tracker). 2. To evaluate…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 o…
Interventions
- DrugOral cannabis low THC
4 months daily dosing with oral cannabis low THC
- DrugPlacebo Comparator
4 months of daily dosing with oral placebo
- DrugOral cannabis high THC
4 months of daily dosing with oral cannabis with high THC
- DrugOral cannabis THC/CBD
4 months of daily dosing with oral cannabis with THC and CBD
Location
- University of KentuckyLexington, Kentucky