Dylan M Zylla1, Justin Eklund2, Grace Gilmore2, Alissa Gavenda2, Jordan Guggisberg2, Gabriela VazquezBenitez3, Pamala A Pawloski3, Tom Arneson4, Sara Richter5, Angela K Birnbaum6, Stephen Dahmer7,8, Matthew Tracy9, Arkadiusz Dudek2. 1. The Cancer Research Center, HealthPartners/Park Nicollet, Minneapolis, MN, USA. dylan.zylla@parknicollet.com. 2. The Cancer Research Center, HealthPartners/Park Nicollet, Minneapolis, MN, USA. 3. HealthPartners Institute, Minneapolis, MN, USA. 4. Minnesota Department of Health, Office of Medical Cannabis, St. Paul, MN, USA. 5. Professional Data Analysts, Minneapolis, MN, USA. 6. University of Minnesota, Minneapolis, MN, USA. 7. Family Medicine & Community Health At the Icahn School of Medicine At Mount Sinai, New York, NY, USA. 8. Vireo Health International, Minneapolis, MN, USA. 9. LeafLine Labs, St. Paul, MN, USA.
Abstract
PURPOSE: The prevalence of medical cannabis (MC) use in patients with cancer is growing, but questions about safety, efficacy, and dosing remain. Conducting randomized, controlled trials (RCTs) using state-sponsored MC programs is novel and could provide data needed to guide patients and providers. METHODS: A pilot RCT of patients with stage IV cancer requiring opioids was conducted. Thirty patients were randomized 1:1 to early cannabis (EC, n = 15) versus delayed start cannabis (DC, n = 15). The EC group obtained 3 months (3 M) of MC through a state program at no charge, while the DC group received standard oncology care without MC for the first 3 M. Patients met with licensed pharmacists at one of two MC dispensaries to determine a suggested MC dosing, formulation, and route. Patients completed surveys on pain levels, opioid/MC use, side effects, and overall satisfaction with the study. RESULTS: Interest in the study was high as 36% of patients who met eligibility criteria ultimately enrolled. The estimated mean daily THC and CBD allotments at 3 M were 34 mg and 17 mg, respectively. A higher proportion of EC patients achieved a reduction in opioid use and improved pain control. No serious safety issues were reported, and patients reported high satisfaction. CONCLUSION: Conducting RCTs using a state cannabis program is feasible. The addition of MC to standard oncology care was well-tolerated and may lead to improved pain control and lower opioid requirements. Conducting larger RCTs with MC in state-sponsored programs may guide oncology providers on how to safely and effectively incorporate MC for interested patients.
PURPOSE: The prevalence of medical cannabis (MC) use in patients with cancer is growing, but questions about safety, efficacy, and dosing remain. Conducting randomized, controlled trials (RCTs) using state-sponsored MC programs is novel and could provide data needed to guide patients and providers. METHODS: A pilot RCT of patients with stage IV cancer requiring opioids was conducted. Thirty patients were randomized 1:1 to early cannabis (EC, n = 15) versus delayed start cannabis (DC, n = 15). The EC group obtained 3 months (3 M) of MC through a state program at no charge, while the DC group received standard oncology care without MC for the first 3 M. Patients met with licensed pharmacists at one of two MC dispensaries to determine a suggested MC dosing, formulation, and route. Patients completed surveys on pain levels, opioid/MC use, side effects, and overall satisfaction with the study. RESULTS: Interest in the study was high as 36% of patients who met eligibility criteria ultimately enrolled. The estimated mean daily THC and CBD allotments at 3 M were 34 mg and 17 mg, respectively. A higher proportion of EC patients achieved a reduction in opioid use and improved pain control. No serious safety issues were reported, and patients reported high satisfaction. CONCLUSION: Conducting RCTs using a state cannabis program is feasible. The addition of MC to standard oncology care was well-tolerated and may lead to improved pain control and lower opioid requirements. Conducting larger RCTs with MC in state-sponsored programs may guide oncology providers on how to safely and effectively incorporate MC for interested patients.
Authors: Ling Hu; Xianfeng Zhang; Zizheng Song; Kunjie Wang; Youchao Jia; Jin Song; Lei Su Journal: Comput Math Methods Med Date: 2022-04-25 Impact factor: 2.809