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Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: a double-blind, placebo controlled, randomised clinical trial of efficacy and safety of cannabidiol (CBD)

Crossref DOI link: https://doi.org/10.1186/s12904-019-0494-6

Published Online: 2019-12-06

Published Print: 2019-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Good, Phillip http://orcid.org/0000-0002-8198-0375
Haywood, Alison

Gogna, Gauri

Martin, Jennifer

Yates, Patsy

Greer, Ristan

Hardy, Janet
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Text and Data Mining valid from 2019-12-01
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Article History

Received: 8 November 2019

Accepted: 21 November 2019

First Online: 6 December 2019

Ethics approval and consent to participate

: The study was approved by the Mater Misericordiae Ltd. Human Research Ethics Committee (EC00332) (MML HREC) on, 10th December 2018 reference number AM/MML/40260 (V1). Minor protocol amendments were approved on 19 December 2018 (V1.1).This study will be conducted in compliance with all stipulations of this protocol, the condition of the ethics committee approval, the NHMRC National Statement of Ethical Conduct in Human Research (2007), the note of Guidance of Good Clinical Practice (CPMP/ICH-135/95), the Australian code for the Responsible Conduct of Research (2007) and all other relevant guidance documents and legislation. The Investigators/Researchers will also comply with their respective professional Codes of Conduct whilst conducting this research, as well as their relevant institutional policies and procedures.The study will be overseen by a data safety monitoring committee consisting of an independent statistician, clinicians, experts in pharmacy and drug addiction and consumer representatives.All participants will give written informed consent to participate in trial.

: Not applicable

: No competing interests to declare.

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