PRIMARY OBJECTIVE:
I. 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.
SECONDARY OBJECTIVES:
I. To evaluate frequency and severity of safety criteria violations from dosing to 4 hours (hrs) post-dose (heart rate [HR], oxygen [O2] saturation from fitness tracker).
II. To evaluate the percent of patients who withdrawal from the study or removed by physician/investigators for all reasons.
III. To determine final tolerated dose for future study (investigator determination after review of adverse events [AEs], participant rated visual analogue scale [VAS], vitals).
IV. To evaluate the effects of cannabis on cancer burden total score, as measured by the prostate-cancer specific National Comprehensive Cancer Network (NCCN)/Functional Assessment of Cancer Therapy (FACT-P) symptom index, a validated questionnaire that assesses cancer burden in the form of symptoms and concerns.
EXPLORATORY OBJECTIVES:
I. To assess the frequency and severity of the following symptoms that are hypothesized to be affected by cannabis, but for which little controlled data is available:
Ia. Quality of life (FACT-P subscales that assess quality of life related to physical, social/family, emotional, and functional well-being);
Ib. Drug effect profile (VAS scores assessing abuse potential, positive/aversive effects and drug tolerability; [Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), 2013; Walsh et al. 2008]; cannabis withdrawal [DSM-5, 2013]; also monitoring for suicidality [Columbia Suicide Severity Rating Scale (C-SSRS), Posner et al., 2011]);
Ic. Appetite (Functional Assessment of Anorexia/Cachexia Therapy [FAACT] anorexia/cachexia subscale [A/CS], 5 items from the subscale of appetite concerns as validated by [Gelhorn et al., 2019]; also one VAS item rating past-week general appetite);
Id. Nausea/vomiting (2 items from the Breast Cancer Prevention Trial [BCPT] subscale [Stanton et al., 2005]);
Ie. Sleep quality (Pittsburgh Sleep Quality Index; also 6 items from the brief version of the scale [Sancho-Domingo et al., 2020]);
If. General mood (Positive and Negative Affect Schedule [PANAS]; VAS scores);
Ig. Pain response (Short-form McGill Pain Questionnaire 2 [SF-MPQ-2]);
Ih. Body weight (measured at once-monthly laboratory visits);
Ii. To evaluate analgesic usage (Kentucky All Schedule Prescription Electronic Reporting System [KASPER], physician notes; self-report items created from Ren et al., 2021; Sohler et al., 2018);
Ij. Hot flashes and night sweats (particularly in those with prostate, breast cancer patients or those who present with these complaints at baseline; 2 items from the BCPT subscale [Stanton et al., 2005]).
II. Pharmacokinetic plasma concentration of novel anti-androgen therapies (abiraterone acetate, enzalutamide, or apalutamide or darolutamide) in prostate cancer patients and oral tyrosine kinase inhibitors (cabozantinib or tivozantinib or lenvatinib/everolimus) in renal cancer patients.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients receive low dose oral (PO) cannabis (THC) for 4 months. Patients also wear a fitness tracker and undergo blood sample collection on study.
ARM II: Patients receive higher dose oral (PO) cannabis (THC) for 4 months. Patients also wear a fitness tracker and undergo blood sample collection on study.
ARM III: Patients receive higher dose oral (PO) cannabis (THC + CBD) for 4 months. Patients also wear a fitness tracker and undergo blood sample collection on study.
ARM IV: Patients receive oral (PO) placebo QD for 4 months. Patients also wear a fitness tracker and undergo blood sample collection on study.
After completion of study intervention, patients are followed up at 30 days.
