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The clinical use of cannabinoid therapies in oncology patients
Published in Betty Wedman-St. Louis, Cannabis, 2018
Paul J. Daeninck, Vincent Maida
As of the date of writing, there are several clinical studies employing cannabinoids in cancer therapy registered at ClinicalTrials.gov. An Israeli group is studying the use of cannabis extracts (cannabidiol) to those patients whose cancers are resistant to the usual chemotherapy protocols (NCT02255292). Two more studies in the preliminary stages include the safety of dexanabinol in patients with advanced cancers (NCT01489826, NCT02423239) and cannabis (high CBD concentration) for pain and inflammation in lung carcinomas (NCT02675842).
The Role of Cannabis and Cannabinoids in Pain Management
Published in Mark V. Boswell, B. Eliot Cole, Weiner's Pain Management, 2005
Dexanabinol is a synthetic cannabinoid agent developed at Hebrew University from Δ8-THC. It is a nonpsychoactive enantiomer of the extremely potent cannabis agonist, HU-210 (Pop, 2000). It has several interesting properties including antioxidant and anti-inflammatory effects, as well as suppression of TNF-α production. Additionally, it reduced damage in experimental focal ischemia, as may be associated with closed head injury (Lavie, Teichner, Shohami, Ovadia, & Leker, 2001). In one human Phase II clinical trial of 67 patients with closed-head injury, dexanabinol reduced intracranial pressure and perfusion significantly with few adverse events (Knoller et al., 2002). Improvements in clinical outcome scales were seen after 3 and 6 months, but were relatively subtle.
Overview of pharmacological interventions after traumatic brain injuries: impact on selected outcomes
Published in Brain Injury, 2019
Sonya Kim, Marianne Mortera, Xiaolei Hu, Shilpa Krishnan, Lilian Hoffecker, Amy Herrold, Lauren Terhorst, Laurie King, Joseph Machtinger, Jennifer M. Zumsteg, Ahmed Negm, Patricia Heyn
The effects of pharmacological treatments on ADL, functional status, disability status, or quality of life (QOL) were addressed in this overview. Alali et al. (42) reported that although beta-blockers administered in the acute phase post-TBI were associated with lower in-hospital mortality, no data on the impact of functional outcomes or QOL measures were noted. Ma et al. (30) reported that progesterone may reduce disability in TBI, but the evidence was insufficient due to small study samples and possible study bias when pooling heterogeneous data on time since injury. Meyer et al. (4) reported a significant improvement at one month post-injury but no longer significant at a six-month follow up when the Disability Rating Scale (DRS) was used by a study following treatment with dexanabinol (103). Moreover, another study by Maas et al. (104) used well-designed randomized controlled trials, but dexanabinol when compared with placebo showed no benefits in long-term functional outcomes. The systematic review of Poole and Agrawal (78) noted that use of the acetylecholinesterase inhibitors (Rivastigmine and Donepezil) showed no statistically significant difference between groups on any functional outcome measures (105); no specific findings reported on functional status (106); and no effect on functional difficulties or improvement in the Functional Independence Measure (FIM) with donepezil (107).
Cannabinoids and bone regeneration
Published in Drug Metabolism Reviews, 2019
Dragos Apostu, Ondine Lucaciu, Alexandru Mester, Horea Benea, Daniel Oltean-Dan, Florin Onisor, Mihaela Baciut, Simion Bran
Drugs containing natural or synthetic cannabinoids have emerged, showing multiple benefits. MarinolTM and SyndrosTM, containing dronabinol – a synthetic THC, together with CesametTM (nabilon), a CB-1 synthetic specific agonist, are used for the treatment of anorexia, nausea and vomiting, mostly in chemotherapy patients, when standard treatment has failed (Bab et al. 2009). SativexTM contains THC and cannabidiol from the marijuana plant, and is indicated in neuropathic pain (Bab et al. 2009). Other drugs including Dexanabinol, CT-3, cannabinor, HU 308, HU 331, Rimonabant and Taranabant are cannabinoid agonists seeking for FDA approval (Apostu et al. 2017).
Cannabis for cancer – illusion or the tip of an iceberg: a review of the evidence for the use of Cannabis and synthetic cannabinoids in oncology
Published in Expert Opinion on Investigational Drugs, 2019
Despite extensive preclinical research and data, antineoplastic efficacy in humans is still mostly anecdotal. Basic and preliminary studies alongside accumulating case reports support the need for large formal RCTs, especially in the treatment of brain tumors and leukemia. In a pilot phase I trial in 2006 where intracranial Δ9-THC was used on nine patients with refractory glioblastoma multiforme (GBM), drug delivery was safe and in two patients, associated with decreased proliferative biomarker expression [76]. In 2011, an article reported spontaneous regression of incompletely resected astrocytomas in two teenagers who were regular consumers of cannabis, and suggested the possible role of cannabis in tumor regression, based merely on the temporal correlation [77]. In 2013, another article reported the case of a child with acute lymphoblastic leukemia for whom different cannabis preparation appeared to have a dose-dependent effect on the number of circulating blasts [78]. More recently, a Phase 2 placebo-controlled study examining a Δ9-THC: CBD [1:1] preparation given in conjunction with temozolomide (TMZ) in 21 patients with recurrent GBM found that the drug was well tolerated and associated with survival advantage, however, the early findings in 2017 have yet to be formally published in a peer-reviewed article [79]. Another phase 1/2 study in a similar patient population assessed concomitant administration of nabiximols and TMZ but has not yet reported results [80]. Finally, two Phase I trials tested dexanabinol, a synthetic cannabinoid derivative that acts as an NMDA receptor antagonist, in patients with advanced solid tumors and brain cancer, respectively, and these, too, have not yet reported results [81,82].