Ketamine Hydrochloride and Best Pain Management in Treating Cancer Patients With Neuropathic Pain

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: University of Glasgow
• Treatments: Ketamine

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