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
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: ketamine hydrochloride
Other: pharmacogenomic studies
Other: questionnaire administration
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: A Randomized Double-Blind Controlled Trial of Ketamine Versus Placebo in Conjunction With Best Pain Management in Neuropathic Pain in Cancer Patients

Resource links provided by NLM:

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U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to treatment failure [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 214
Study Start Date: April 2009
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316744

Locations
United Kingdom
Royal Brompton Hospital Recruiting
London, England, United Kingdom, SW3 6NP
Contact: Contact Person    44-207-886-6011    c.urch@ucl.ac.uk   
Edinburgh Cancer Centre at Western General Hospital Recruiting
Edinburgh, Scotland, United Kingdom, EH4 2XR
Contact: Contact Person    44-131-777-3520    marie.fallon@ed.ac.uk   
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, Scotland, United Kingdom, G12 0YN
Contact: Contact Person    44-141-301-7033    john.welsh@ggc.scot.nhs.uk   
Sponsors and Collaborators
University of Glasgow
Investigators
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01316744     History of Changes
Other Study ID Numbers: CDR0000696704, CRUK-KPS-2008-01, EU-21012, EUDRACT-2007-002080-27, ISRCTN-49116945
Study First Received: March 15, 2011
Last Updated: May 12, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
long-term effects secondary to cancer therapy in adults
anxiety disorder
depression
pain
unspecified adult solid tumor, protocol specific
neuropathy
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia, BCR-ABL1 negative
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
mast cell leukemia
meningeal chronic myelogenous leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult T-cell leukemia/lymphoma
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neuralgia
Lymphoma, Large-Cell, Immunoblastic
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on September 11, 2014