A randomised, double-blind controlled trial of ketamine versus placebo in conjunction with best pain management in neuropathic pain in cancer patients - KPS

Conditions: Patients who have neuropathic pain related to cancer and/or treatment for cancer (surgical, chemotherapy or radiotherapy) which has resulted in neuropathic pain.
MedDRA version: 9.1Level: LLTClassification code 10059513Term: Palliative care
MedDRA version: 3.0Level: LLTClassification code 10033470Term: <Manually entered code. Term in E.1.1>

Registration Number: EUCTR2007-002080-27-GB

Lead Sponsor: Greater Glasgow Health Board/University of Glasgow

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 214

Inclusion Criteria

•> 18 years of age
•Patient has a histological proven cancer diagnosis
•Written informed consent (to be obtained within 28 days prior to entry into the study)
•Index neuropathic pain (as defined by LANSS) that is related to underlying malignancy or resulting from treatment received for this
•Index neuropathic pain >= 4 on 0-10 (VAS)
•McGill Sensory Scale Score > 5
•Patient has had a trial of at least one adjuvant analgesic (gabapentin, pregabalin, amitriptyline) or has been offered these and declined
•Patient is able to comply with study procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients who have received chemotherapy or radiotherapy in the preceding six weeks that is likely to affect neuropathic pain
•Patients who may have a change in tumoricidal treatment during the period of the study that is likely to alter pain during the course of the study
•Diastolic blood pressure > 100mmHg at screening
•History of seizures in last 2 years
•Patient is currently taking class I anti-arrhythmic drugs
•Life expectancy less than two months
•Patients who are actively hallucinating
•Women of childbearing potential who are not using adequate contraception
•Patients with cerebrovascular disease (strokes)
•Patients with psychotic disorders or cognitive impairment