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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.

Λεπτομέρειες βιβλιογραφικής εγγραφής
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.
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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  – Url: https://hdl.handle.net/2013/ULB-DIPOT:oai:dipot.ulb.ac.be:2013/144691#
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  Data: 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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  Data: Journal of pain and symptom management
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  Data: DI-fusion : dépôt institutionnel de l'Université libre de Bruxelles (ULB)
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  Data: <searchLink fieldCode="DE" term="%22Cancérologie%22">Cancérologie</searchLink><br /><searchLink fieldCode="DE" term="%22Administration%22">Administration</searchLink><br /><searchLink fieldCode="DE" term="%22Oral%22">Oral</searchLink><br /><searchLink fieldCode="DE" term="%22Aerosols+--+administration+%26+dosage+--+adverse+effects%22">Aerosols -- administration & dosage -- adverse effects</searchLink><br /><searchLink fieldCode="DE" term="%22Analgesics%22">Analgesics</searchLink><br /><searchLink fieldCode="DE" term="%22Non-Narcotic+--+administration+%26+dosage+--+adverse+effects%22">Non-Narcotic -- administration & dosage -- adverse effects</searchLink><br /><searchLink fieldCode="DE" term="%22Opioid+--+adverse+effects+--+therapeutic+use%22">Opioid -- adverse effects -- therapeutic use</searchLink><br /><searchLink fieldCode="DE" term="%22Belgium+--+epidemiology%22">Belgium -- epidemiology</searchLink><br /><searchLink fieldCode="DE" term="%22Dose-Response+Relationship%22">Dose-Response Relationship</searchLink><br /><searchLink fieldCode="DE" term="%22Drug%22">Drug</searchLink><br /><searchLink fieldCode="DE" term="%22Dronabinol+--+administration+%26+dosage+--+adverse+effects%22">Dronabinol -- administration & dosage -- adverse effects</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+Tolerance%22">Drug Tolerance</searchLink><br /><searchLink fieldCode="DE" term="%22Female%22">Female</searchLink><br /><searchLink fieldCode="DE" term="%22Follow-Up+Studies%22">Follow-Up Studies</searchLink><br /><searchLink fieldCode="DE" term="%22Great+Britain+--+epidemiology%22">Great Britain -- epidemiology</searchLink><br /><searchLink fieldCode="DE" term="%22Humans%22">Humans</searchLink><br /><searchLink fieldCode="DE" term="%22Longitudinal+Studies%22">Longitudinal Studies</searchLink><br /><searchLink fieldCode="DE" term="%22Male%22">Male</searchLink><br /><searchLink fieldCode="DE" term="%22Middle+Aged%22">Middle Aged</searchLink><br /><searchLink fieldCode="DE" term="%22Neoplasms+--+complications+--+diagnosis+--+nursing%22">Neoplasms -- complications -- diagnosis -- nursing</searchLink><br /><searchLink fieldCode="DE" term="%22Pain+Measurement+--+drug+effects%22">Pain Measurement -- drug effects</searchLink><br /><searchLink fieldCode="DE" term="%22Pain%22">Pain</searchLink><br /><searchLink fieldCode="DE" term="%22Intractable+--+diagnosis+--+drug+therapy+--+etiology%22">Intractable -- diagnosis -- drug therapy -- etiology</searchLink><br /><searchLink fieldCode="DE" term="%22Palliative+Care+--+methods%22">Palliative Care -- methods</searchLink><br /><searchLink fieldCode="DE" term="%22Terminal+Care+--+methods%22">Terminal Care -- methods</searchLink><br /><searchLink fieldCode="DE" term="%22Treatment+Failure%22">Treatment Failure</searchLink><br /><searchLink fieldCode="DE" term="%22Treatment+Outcome%22">Treatment Outcome</searchLink>
– Name: Abstract
  Label: Description
  Group: Ab
  Data: 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
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      – Text: English
    Subjects:
      – SubjectFull: Cancérologie
        Type: general
      – SubjectFull: Administration
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      – SubjectFull: Oral
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      – SubjectFull: Aerosols -- administration & dosage -- adverse effects
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      – SubjectFull: Dronabinol -- administration & dosage -- adverse effects
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      – TitleFull: 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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