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

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ClinicalTrials.gov Identifier: NCT01316744
Recruitment Status : Unknown
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : March 16, 2011
Last Update Posted : May 13, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE March 15, 2011
First Posted Date  ICMJE March 16, 2011
Last Update Posted Date May 13, 2011
Study Start Date  ICMJE April 2009
Estimated Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2011)
Time to treatment failure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2011)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Hydrochloride and Best Pain Management in Treating Cancer Patients With Neuropathic Pain
Official Title  ICMJE 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 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.

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. Patients who have improved pain scores (i.e., < 4/10 on the visual-analogue score in the past 24 hours or < 5 McGill Sensory Scale Score) are taken off the study. Patients whose scores have not improved continue on to Stage 2 of the study.

NOTE: *Stable regimen is defined as the same dose of controlled release and no more variation than 2 breakthrough opioid doses over the normal for that patient for a period of 48 hours.

  • Stage 2 (Titration Period): Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive oral ketamine hydrochloride 4 times a day. Doses are titrated until when analgesia is achieved or individual side effects appear, for up to 14 days.
    • Arm II: Patients receive an oral placebo 4 times a day. Doses are titrated until when analgesia is achieved or individual side effects appear, for up to 14 days.
  • Stage 3 (Assessment Period): Patients receive the trial medication (i.e., ketamine hydrochloride or placebo) at the fixed optimum dose (reached during the titration period) for 16 days.

Patients are allowed to receive breakthrough opioids at any time during the study.

Patients complete quality-of-life and pain-assessment questionnaires periodically. Some patients may undergo blood sample collection periodically for pharmacogenomics studies at a later date.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE
  • Drug: ketamine hydrochloride
  • Other: pharmacogenomic studies
  • Other: questionnaire administration
  • Procedure: assessment of therapy complications
  • Procedure: quality-of-life assessment
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 15, 2011)
214
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01316744
Other Study ID Numbers  ICMJE CDR0000696704
CRUK-KPS-2008-01
EU-21012
EUDRACT-2007-002080-27
ISRCTN-49116945
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Glasgow
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie T. Fallon Edinburgh Cancer Centre at Western General Hospital
Principal Investigator: Barry J.A. Laird, MD Edinburgh Cancer Centre at Western General Hospital
PRS Account National Cancer Institute (NCI)
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP