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|Title||A Double-Blind, Placebo-Controlled, Crossover Pilot Trial With Extension Using an Oral Mucosal Cannabinoid Extract for Treatment of Chemotherapy-Induced Neuropathic Pain.|
|Author(s)|| Lynch ME, Cesar-Rittenberg P, Hohmann AG.|
|Journal, Volume, Issue||J Pain Symptom Manage. 2013 Jun 4. pii: S0885-3924(13)00238-8. doi: 10.1016/j.jpainsymman.2013.02.018. [Epub ahead of print]|
|Major outcome(s)||Five patients tended to respond to a treatment with cannabis|
CONTEXT: Neuropathic pain caused by chemotherapy limits dosing and duration of
potentially life-saving anti-cancer treatment and impairs quality of life.
Chemotherapeutic neuropathy responds poorly to conventional treatments, and there
is an urgent medical need for new treatments. Recent preclinical studies
demonstrate that cannabinoid agonists suppress established chemotherapy-evoked
neuropathy. OBJECTIVES: This was a pilot trial to begin to investigate a
currently available cannabinoid agent, nabiximols (oral mucosal spray containing
cannabinoids), in the treatment of chemotherapy-induced neuropathic pain.
METHODS: A randomized, placebo-controlled crossover pilot study was done in 16
patients with established chemotherapy-induced neuropathic pain. A 0-10 point
numeric rating scale for pain intensity (NRS-PI) was used as the primary outcome
measure. RESULTS: When examining the whole group, there was no statistically
significant difference between the treatment and the placebo groups on the
NRS-PI. A responder analysis demonstrated that there were five participants who
reported a two-point or greater reduction in pain that trended toward statistical
significance and the number needed to treat was five. CONCLUSION:
Chemotherapy-induced neuropathic pain is particularly resistant to currently
available treatments. This pilot trial found a number needed to treat of five and
an average decrease of 2.6 on an 11-point NRS-PI in five "responders" (as
compared with a decrease of 0.6 with placebo) and supports that it is worthwhile
to study nabiximols in a full randomized, placebo-controlled trial of
chemotherapy-induced neuropathic pain.
|Participants||16 patients suffering from chemotherapy-induced neuropathic |
|Type of publication||Medical journal|
|Address of author(s)|| Pain Management Unit, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, Nova Scotia, Canada; Department of Anesthesia, Psychiatry and Pharmacology, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: mary.lync|