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Clinical Trials/NCT01316744
NCT01316744UnknownPhase 3

A Randomized Double-Blind Controlled Trial of Ketamine Versus Placebo in Conjunction With Best Pain Management in Neuropathic Pain in Cancer Patients

University of Glasgow3 sites in 1 country214 target enrollmentStarted: April 1, 2009Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Enrollment
214
Locations
3
Primary Endpoint
Time to treatment failure
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Detailed Description

OBJECTIVES:

Primary

  • To determine whether ketamine hydrochloride given in addition to best standard pain management improves malignant neuropathic pain compared to best standard pain management alone in patients with cancer.

Secondary

  • To compare initial treatment benefit (at day 4 of assessment period of 16 days) using the sensory component of the McGill Short-Form Questionnaire.
  • To compare difference in overall pain between the study arms based on the pain-intensity visual-analogue score (VAS).
  • To compare difference in neuropathic pain between the study arms based on the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale.
  • To assess worst pain score (index neuropathic site) between the two arms.
  • To compare patient distress between the two arms based on NCCN Distress Thermometer.
  • To assess the side effects and tolerability of trial drug.
  • To assess the effect of intervention on quality of life scores (based on Euroqol thermometer), anxiety and depression (based on HADS), and opioid requirements.

Study Design

Study Type
Interventional
Allocation
Randomized
Primary Purpose
Supportive Care
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Time to treatment failure

Secondary Outcomes

  • Side effects and tolerability of trial drug
  • Effect of the intervention on quality-of-life scores (based on Euroqol thermometer), anxiety and depression (based on HAD scale), and opioid requirements
  • Initial treatment benefit (at day 4 of assessment period of 16 days) using the sensory component of the McGill Short-Form Questionnaire
  • Difference in overall pain between the study arms based on the visual-analogue score
  • Difference in neuropathic pain between the study arms based on the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
  • Worst pain score (index neuropathic site) in the previous 24 hours (between the two arms) at study baseline and then during study assessment period
  • Patient distress between the two arms based on NCCN Distress Thermometer

Investigators

Sponsor Class
Other

Study Sites (3)

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