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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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.

OUTLINE: This is a multicenter study.

  • Stage 1 (Run-in Period): Opioid doses are optimized, under a defined schedule, for up to a maximum of 10 days to ensure that all patients are on an optimized and stable regimen* prior to randomization. Following the run-in-period, patients undergo reassessment. Patient
    Sponsor: University of Glasgow

    Current Primary Outcome: Time to treatment failure

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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
    • 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


    Original Secondary Outcome: Same as current

    Information By: National Cancer Institute (NCI)

    Dates:
    Date Received: March 15, 2011
    Date Started: April 2009
    Date Completion:
    Last Updated: May 12, 2011
    Last Verified: March 2011