Academic Journal
An Open-Label Extension Study to Investigate the Long-Term Safety and Tolerability of THC/CBD Oromucosal Spray and Oromucosal THC Spray in Patients With Terminal Cancer-Related Pain Refractory to Strong Opioid Analgesics.
| Τίτλος: | An Open-Label Extension Study to Investigate the Long-Term Safety and Tolerability of THC/CBD Oromucosal Spray and Oromucosal THC Spray in Patients With Terminal Cancer-Related Pain Refractory to Strong Opioid Analgesics. |
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| Συγγραφείς: | Johnson, Jeremy R, Lossignol, Dominique, Burnell-Nugent, Mary, Fallon, Marie T |
| Πηγή: | Journal of pain and symptom management |
| Έτος έκδοσης: | 2012 |
| Συλλογή: | DI-fusion : dépôt institutionnel de l'Université libre de Bruxelles (ULB) |
| Θεματικοί όροι: | Cancérologie, Administration, Oral, Aerosols -- administration & dosage -- adverse effects, Analgesics, Non-Narcotic -- administration & dosage -- adverse effects, Opioid -- adverse effects -- therapeutic use, Belgium -- epidemiology, Dose-Response Relationship, Drug, Dronabinol -- administration & dosage -- adverse effects, Drug Tolerance, Female, Follow-Up Studies, Great Britain -- epidemiology, Humans, Longitudinal Studies, Male, Middle Aged, Neoplasms -- complications -- diagnosis -- nursing, Pain Measurement -- drug effects, Pain, Intractable -- diagnosis -- drug therapy -- etiology, Palliative Care -- methods, Terminal Care -- methods, Treatment Failure, Treatment Outcome |
| Περιγραφή: | CONTEXT: Chronic pain in patients with advanced cancer poses a serious clinical challenge. The Δ9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (U.S. Adopted Name, nabiximols; Sativex(®)) is a novel cannabinoid formulation currently undergoing investigation as an adjuvant therapy for this treatment group. OBJECTIVES: This follow-up study investigated the long-term safety and tolerability of THC/CBD spray and THC spray in relieving pain in patients with advanced cancer. METHODS: In total, 43 patients with cancer-related pain experiencing inadequate analgesia despite chronic opioid dosing, who had participated in a previous three-arm (THC/CBD spray, THC spray, or placebo), two week parent randomized controlled trial, entered this open-label, multicenter, follow-up study. Patients self-titrated THC/CBD spray (n=39) or THC spray (n=4) to symptom relief or maximum dose and were regularly reviewed for safety, tolerability, and evidence of clinical benefit. RESULTS: The efficacy end point of change from baseline in mean Brief Pain Inventory-Short Form scores for "pain severity" and "worst pain" domains showed a decrease (i.e. improvement) at each visit in the THC/CBD spray patients. Similarly, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 scores showed a decrease (i.e. improvement) from baseline in the domains of insomnia, pain, and fatigue. No new safety concerns associated with the extended use of THC/CBD spray arose from this study. CONCLUSION: This study showed that the long-term use of THC/CBD spray was generally well tolerated, with no evidence of a loss of effect for the relief of cancer-related pain with long-term use. Furthermore, patients who kept using the study medication did not seek to increase their dose of this or other pain-relieving medication over time, suggesting that the adjuvant use of cannabinoids in cancer-related pain could provide useful benefit. ; JOURNAL ARTICLE ; info:eu-repo/semantics/published |
| Τύπος εγγράφου: | article in journal/newspaper |
| Περιγραφή αρχείου: | 1 full-text file(s): application/pdf |
| Γλώσσα: | English |
| Relation: | uri/info:doi/10.1016/j.jpainsymman.2012.07.014; uri/info:pmid/23141881; https://dipot.ulb.ac.be/dspace/bitstream/2013/144691/1/Elsevier_128458.pdf |
| Διαθεσιμότητα: | https://hdl.handle.net/2013/ULB-DIPOT:oai:dipot.ulb.ac.be:2013/144691 https://dipot.ulb.ac.be/dspace/bitstream/2013/144691/1/Elsevier_128458.pdf |
| Αριθμός Καταχώρησης: | edsbas.885F1F65 |
| Βάση Δεδομένων: | BASE |
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