Sativex for Treatment of Chemotherapy Induced Neuropathic Pain
This study is ongoing, but not recruiting participants.
Sponsor:
Mary Lynch
Information provided by (Responsible Party):
Mary Lynch, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00872144
First received: March 25, 2009
Last updated: November 1, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 ]
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated 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
No publications provided
| 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: | November 1, 2012 |
| 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 June 18, 2013