Evaluation of Safety, Efficacy, and Clinical Endpoints of Delta-9-Tetrahydrocannabinol in Patients Age 60 or Older with Hematologic and Oncologic Malignancies

Background: Many cancer patients are utilizing Cannabis to treat their cancer related symptoms either by prescription or not. Clinical studies evaluating safety and efficacy of Cannabis are lacking. Dronabinol, synthetic delta-9-tetrahydrocannabinol (Δ-9-thc), is the active compound & natural occurring component of Cannabis Sativa L (Marijuana). Dronabinol is used as an appetite stimulant & treatment of chemo induced nausea/vomiting in cancer patients (pts). Here we evaluate the efficacy, safety, & other clinical endpoints in older cancer pts. Methods: Survey study administered to cancer pts prescribed Dronabinol w/ 7 questions (yes/no/n/a): Did Dronabinol increase appetite? decrease nausea/vomiting? improve mood? decrease insomnia? decrease anxiety? have any side effects? improve quality of life (QOL)? Also pts were asked if they preferred synthetic meds vs natural plant based meds (oil, capsule, liquid, etc.). Inclusion: age ≥ 60, hem/onc malignancy, prescribed Dronabinol. Exclusion: death, altered mental status, not taking Dronabinol, off label use. Unpaired t-test w/ two sided P value used to compare differences. Results: N = 40 pts enrolled, 12 pts excluded, 28 pts meeting study criteria. Mean age 71 w/ range 60-89 year old. Race: 97% Caucasian & 3% African American. Ethnicity: 93% Latin 7% non-Latin. Gender: 50% male 50% female. Clinical: 79% Oncologic vs. 21% Hematologic malignancy. Dose given: 2.5 mg QD (18%), 2.5 mg BID (71%), 5mg BID (11%). Significant improvements in appetite (93% improvement vs. 7% no improvement = < 0.0001), nausea (86% vs. 14% p = < 0.0001), vomiting (83% vs. 17%, p = 0.0004), mood (78% vs. 22% p = < 0.0001), sleep (80% vs. 20%, p = < 0.0001), anxiety (86% vs. 14%, p = < 0.0001), QOL (89% vs. 11% p = < 0.0001) observed. No side effects seen in 86 % vs. 14% of pts, p = < 0.0001. Of pts w/ side effects: 75% dizziness, 25% "felt high". 64% vs 36%, p = < 0.07 of pts preferred natural plant based meds vs. synthetic meds. Conclusions: This unique study shows Dronabinol significantly improved appetite, nausea, vomiting, mood, sleep, anxiety, & QOL in older cancer pts w/ most pts having no side effects. Also, the majority of patients derived clinical benefit from lower doses (2.5 mg QD or BID) than what is typically recommended. Further investigations examining the clinical benefits & safety of Dronabinol & Cannabis Sativa L are warranted in older cancer patients.