A Phase I Study of the Effects of Cannabis on Cancer Burden: Placebo-Controlled, Double-Blind, Randomized Trial

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 the percent of patients who withdrawal from the study or removed by physician/investigators for all reasons.
3. To determine final tolerated dose for future study (investigator determination after review of AEs, participant rated VAS, vitals).
4. To evaluate the effects of cannabis on cancer burden total score, as measured by the NCCN/Functional Assessment of Cancer Therapy (FACT) Symptom Index, a validated questionnaire that assesses cancer burden in the form of symptoms and concerns. Specifically, 17 items form 4 subscales that assess Disease-Related Symptoms-Physical (DRS-P), Disease- Related Symptoms-Emotional (DRS-E), Treatment Side Effects (TSE), and Function/Well-Being (F/WB). A total score is generated and will be assessed at baseline, during experimental dosing and follow-up.

Participants: Participants will be adult cancer patients, ages 18 and older, who have a histologically or cytologically confirmed locally advanced or metastatic solid tumor. These patients will be actively undergoing anti-cancer therapy, having been on a current regimen for at least one month prior to enrollment. An ECOG performance status of ≤2 and adequate organ and marrow function at baseline is required. A total of 80 patients will be enrolled in this study (n=20/arm).

Investigators will recruit participants from the University of Kentucky Markey Cancer Center. Patients who appear to meet basic/initial study criteria will be approached by Dr. and Doctor's team. Investigators will provide the patient with a study information card that contains basic information about the study and the contact information (e.g., phone, text, email, social media contacts) for the UK Center on Drug and Alcohol Research (CDAR; Dr. Babalonis and her team). When contacting the CDAR, the participant will have a chance to speak to staff and ask questions and will also have the opportunity to schedule an in-person screening appointment (the first of two in-person screening appointments).