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