UnknownPhase 3ketamine
Ketamine Hydrochloride and Best Pain Management in Treating Cancer Patients With Neuropathic Pain
Sponsored by University of Glasgow
NCT ID
NCT01316744
Target Enrollment
214 participants
Start Date
2009-04
About This Study
RATIONALE: Ketamine hydrochloride may lessen neuropathic pain in patients with cancer. It is not yet known whether ketamine hydrochloride given together with the best pain management is more effective than a placebo given together with the best pain management in treating neuropathic pain in patients with cancer. PURPOSE: This randomized phase III trial is studying ketamine hydrochloride given together with the best pain management to see how well it works compared with giving a placebo together with the best pain management in treating cancer patients with neuropathic pain.
Conditions Studied
Interventions
- •ketamine hydrochloride
- •pharmacogenomic studies
- •questionnaire administration
- •assessment of therapy complications
- •quality-of-life assessment
Eligibility
Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
DISEASE CHARACTERISTICS: * Histologically confirmed cancer * Index neuropathic pain ≥ 4 on 0-10 (as defined by Leeds Assessment of Neuropathic Symptoms and Signs) that is related to underlying malignancy or resulting from treatment received for this malignancy * McGill Sensory Scale Score \> 5 * Received a trial of an adjuvant analgesic (gabapentin or amitriptyline or both) PATIENT CHARACTERISTICS: * Life expectancy ≥ 2 months * Fertile patients must use effective contraception * Able to comply with study procedures * Diastolic blood pressure ≤ 100 mm Hg at screening * No seizures in past 2 years * Not actively hallucinating * No cerebrovascular disease (strokes) * No psychotic disorders or cognitive impairment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 6 weeks since prior and no concurrent chemotherapy or radiotherapy that is likely to affect neuropathic pain * No change in tumoricidal treatment during the period of the study that is likely to alter pain during the course of the study * No concurrent class I antiarrhythmic drugs
Study Locations (3)
Royal Brompton Hospital
London, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom