Overview

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