Sativex for Treatment of Chemotherapy Induced Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mary Lynch, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00872144
First received: March 25, 2009
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Neuropathic Pain
Drug: Sativex
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2010
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872144

Locations
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre, Pain Management Unit
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Mary Lynch
Investigators
Principal Investigator: Mary E Lynch, MD Capital District Health Authority, Canada
  More Information

Publications:
Responsible Party: Mary Lynch, MD FRCPC, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00872144     History of Changes
Other Study ID Numbers: CDHA-RS/2009-316
Study First Received: March 25, 2009
Last Updated: March 5, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014