Sativex for Treatment of Chemotherapy Induced Neuropathic Pain

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mary Lynch
• Treatments: Nabiximols

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