Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01316744
First received: March 15, 2011
Last updated: May 12, 2011
Last verified: March 2011

March 15, 2011
May 12, 2011
April 2009
October 2011   (final data collection date for primary outcome measure)
Time to treatment failure [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01316744 on ClinicalTrials.gov Archive Site
  • Initial treatment benefit (at day 4 of assessment period of 16 days) using the sensory component of the McGill Short-Form Questionnaire [ Designated as safety issue: No ]
  • Difference in overall pain between the study arms based on the visual-analogue score [ Designated as safety issue: No ]
  • Difference in neuropathic pain between the study arms based on the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale [ Designated as safety issue: Yes ]
  • Worst pain score (index neuropathic site) in the previous 24 hours (between the two arms) at study baseline and then during study assessment period [ Designated as safety issue: No ]
  • Patient distress between the two arms based on NCCN Distress Thermometer [ Designated as safety issue: No ]
  • Side effects and tolerability of trial drug [ Designated as safety issue: Yes ]
  • Effect of the intervention on quality-of-life scores (based on Euroqol thermometer), anxiety and depression (based on HAD scale), and opioid requirements [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ketamine Hydrochloride and Best Pain Management in Treating Cancer Patients With Neuropathic Pain
A Randomized Double-Blind Controlled Trial of Ketamine Versus Placebo in Conjunction With Best Pain Management in Neuropathic Pain in Cancer Patients

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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Cancer
  • Drug: ketamine hydrochloride
  • Other: pharmacogenomic studies
  • Other: questionnaire administration
  • Procedure: assessment of therapy complications
  • Procedure: quality-of-life assessment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
214
Not Provided
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United Kingdom
 
NCT01316744
CDR0000696704, CRUK-KPS-2008-01, EU-21012, EUDRACT-2007-002080-27, ISRCTN-49116945
Not Provided
Not Provided
University of Glasgow
Not Provided
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
National Cancer Institute (NCI)
March 2011

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