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A randomized trial of medical cannabis in patients with stage IV cancers to assess feasibility, dose requirements, impact on pain and opioid use, safety, and overall patient satisfaction

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.

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Data availability

The authors have full control of all primary data and agree to allow the journal to review data if requested.

Code availability

Not applicable.

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Funding

This work was supported by grants received from HealthPartners Institute; Randy Shaver Cancer Research and Community Fund; and philanthropic support from Diana and Bob Carter. No grant numbers are applicable. Vireo Health and LeafLine Labs provided all cannabis products at no cost to the patients during the trial period.

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Affiliations

Authors

Contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Dylan Zylla, Justin Eklund, Grace Gilmore, Jordan Guggisberg, Gabriela BaazquezBenitez, Sara Richter, and Angela Birnbaum. The first draft of the manuscript was written by Dylan Zylla, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Dylan M. Zylla.

Ethics declarations

Ethics approval

This research involved human participants and was performed in line with the principles of the Declaration of Helsinki. Approval was granted by HealthPartners Institutional Review Board.

Consent to participate

Informed consent was obtained from all patients.

Consent for publication

Not applicable.

Conflict of interest

Dr. Dahmer has received personal compensation for serving as an employee of Vireo Health International. Matthew Tracy is employed by LeafLine Labs. The remaining authors have no conflict of interest to declare that are relevant to the content of this article.

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Cite this article

Zylla, D.M., Eklund, J., Gilmore, G. et al. A randomized trial of medical cannabis in patients with stage IV cancers to assess feasibility, dose requirements, impact on pain and opioid use, safety, and overall patient satisfaction. Support Care Cancer 29, 7471–7478 (2021). https://doi.org/10.1007/s00520-021-06301-x

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Keywords

  • Medical cannabis
  • Pain
  • Opioids
  • Cancer
  • Patient-reported outcomes