Impact of Daily Oral Cannabis Doses in Patients With Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanna Babalonis, PhD
About this trial
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
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Oral cannabis low THC
- Placebo Comparator
- Oral cannabis high THC
- Oral cannabis THC/CBD
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Shanna Babalonis, PhD
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov