Sativex for Treatment of Chemotherapy Induced Neuropathic Pain

NCT00872144 | Completed Phase 3

• 1 other identifier: CDHA-RS/2009-316
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

• Change in the NRS-PI from baseline to the final week of stable dose treatment)

  Patients will titrate the dose to a level where they obtain an analgesic effect without limiting side effects (week 3)

• Participants gaining a 30% or greater reduction in the NRS-PI

  Patients will titrate the dose to a level where they obtain an analgesic effect without limiting side effects (week 3)

Secondary Outcomes (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

  After stable dosing is achieved (week 3)

Study Arms (1)

Sativex

ACTIVE COMPARATOR

Drug: Sativex

Interventions

Sativex DRUG

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.

Sativex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mary Lynch: lead

Study Sites (1)

Queen Elizabeth II Health Sciences Centre, Pain Management Unit

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Publications (1)

• Lynch ME, Cesar-Rittenberg P, Hohmann AG. A double-blind, placebo-controlled, crossover pilot trial with extension using an oral mucosal cannabinoid extract for treatment of chemotherapy-induced neuropathic pain. J Pain Symptom Manage. 2014 Jan;47(1):166-73. doi: 10.1016/j.jpainsymman.2013.02.018. Epub 2013 Jun 4.

  PMID: 23742737 RESULT

MeSH Terms

Conditions

Neuralgia

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary E Lynch, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD FRCPC

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 31, 2009
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

CA (1)