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Sativex for Treatment of Chemotherapy Induced Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00872144
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : March 7, 2014
Information provided by (Responsible Party):
Mary Lynch, Nova Scotia Health Authority

Brief Summary:
Chemotherapy is often used to treat cancer and in many cases can cure it or extend life. Unfortunately many of the chemotherapeutic agents used in treating cancer can cause nerve damage, resulting in severe pain involving the extremities. This "neuropathic" pain causes significant suffering in cancer survivors and may also limit the amount of chemotherapy patients are able to tolerate in attempting to treat the cancer. There is evidence that cannabinoids can suppress chemotherapy evoked neuropathy in animal models, in some cases better than morphine. This study proposes to examine the effect of a cannabinoid extract (Sativex) in treatment of neuropathic pain caused by chemotherapy.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: Sativex Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind Placebo Controlled Crossover Pilot Trial of Sativex With Open Label Extension for Treatment of Chemotherapy Induced Neuropathic Pain
Study Start Date : June 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Active Comparator: Sativex Drug: Sativex
Sativex (or placebo) will be dispensed identical 5.5 ml containers. Participants will be instructed to start with a dose of 1 spray trans-mucosally at 1800 hrs. If there are no limiting adverse effects such as sedation or dizziness, participants will be instructed to increase the dose to 2 sprays- one in the morning and the other in the early evening on day two. Participants may increase the dose by 1-2 sprays per day to a maximum dose of 12 sprays per day given 3 sprays 4 times per day. In the initial titration phase participants will be instructed to space each dose actuation 15 minutes apart until accustomed to the preparation. Participants will titrate the dose to a level where they obtain an analgesic effect without limiting side effects.

Primary Outcome Measures :
  1. Change in the NRS-PI from baseline to the final week of stable dose treatment) [ Time Frame: Patients will titrate the dose to a level where they obtain an analgesic effect without limiting side effects (week 3) ]
  2. Participants gaining a 30% or greater reduction in the NRS-PI [ Time Frame: Patients will titrate the dose to a level where they obtain an analgesic effect without limiting side effects (week 3) ]

Secondary Outcome Measures :
  1. Secondary outcome measures will include measures in the remaining domains (suggested by IMMPACT). These include SF36, Quantitative sensory examination, Global Impression of Change, PGIC and Patient Satisfaction Scale, PSS [ Time Frame: After stable dosing is achieved (week 3) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >18 years
  • Neuropathic pain beginning after chemotherapy with paclitaxil, vincristine or cis-platin that has been present for 3 months or longer.
  • Presence of allodynia, hyperalgesia or hypoesthesia on sensory testing in the area of pain.
  • Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI).
  • Medications must have been stable for at least14 days.
  • Ability to follow the protocol
  • Willing and able to give written informed consent.

Exclusion Criteria:

  • Ischemic heart disease
  • Personal history of schizophrenia or psychotic disorder
  • Family history of schizophrenia or psychotic disorder in first degree family member (parent, sibling or child)
  • Allergy to cannabinoids
  • Presence of any other clinically significant medical disorder (other than the cancer requiring chemotherapy) on history or physical exam that would compromise the participants' safety in the trial as judged by the study physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00872144

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Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre, Pain Management Unit
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Mary Lynch
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Principal Investigator: Mary E Lynch, MD Nova Scotia Health Authority
Publications of Results:
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Responsible Party: Mary Lynch, MD FRCPC, Nova Scotia Health Authority Identifier: NCT00872144    
Other Study ID Numbers: CDHA-RS/2009-316
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs