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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN49116945 |
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Date of registration:
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27/04/2007 |
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Primary sponsor: |
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Public title:
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A randomised double-blind controlled trial of s-ketamine versus placebo in conjunction with best pain management in neuropathic pain in cancer patients
KPS (Ketamine in Pain Study) |
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Scientific title:
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Date of first enrolment:
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Jun 1 2007 |
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Target sample size:
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214 |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN49116945 |
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Study type:
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Interventional |
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Study design:
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A randomised double blind design will be applied with both arms receiving standard best pain management.
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Marie
Fallon |
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Address:
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Palliative Medicine/Oncology
Edinburgh Cancer Centre
University of Edinburgh
Western General Hospital
Crewe Road
EH4 2 XU
Edinburgh
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged greater than or equal to 18 years of age
2. Written informed consent
3. Neuropathic pain (as defined by the Leeds Assessment of Neuropathic Symptoms and Signs [LANSS]) that is related to underlying malignant disease
4. Neuropathic Pain greater than or equal to four on a zero to ten (Visual Analogue Scale [VAS]) and a McGill Sensory Scale Score greater than five
5. Will have had a trial of an adjuvant analgesic (gabapentin or amitriptyline)
Exclusion criteria: 1. Planned to receive chemotherapy or radiotherapy which may change pain during the period of the study
2. Diastolic Blood Pressure greater than 100 mmHg
3. History of seizures in last two years
4. Class I anti-arrhythmic drugs
5. Life expectancy less than two months
6. Patients who are actively hallucinating
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Neuropathic pain in cancer patients
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Intervention(s)
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Following a run-in period where opioid analgesia dose will be optimised (duration: 2 to 10 days), s-ketamine or placebo will be administered orally four times a day. The dose will be increased as per the titration schedule and dose increments will cease when pain or toxicity allow (duration 2 to 14 days until study medication titrated to maximum effect without side effects).
Assessment period - once study medication is completed patient enters 4 x four day assessment period to collect outcome data.
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Primary Outcome(s)
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To establish whether s-ketamine given in addition to best standard pain management improves malignant neuropathic pain compared to best standard pain management alone. This is assessed using the sensory component of the McGill Short Form Questionnaire.
Timepoint: from the end of the run in period (prior to randomisation) at any one of the assessment time points (day 0 - end of titration period), day 4, day 8, day 12, day 16.
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Secondary Outcome(s)
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1. To compare initial treatment benefit (at day 4 of assessment period of 16 days) using the sensory component of the McGill Short Form Questionnaire (timepoint : day 4 of assessment period of 16 days)
2. To compare difference in overall pain between the study arms based on the pain intensity (VAS score) (timepoint : daily throughout run in, titration and assessment period)
3. To compare difference in neuropathic pain between the study arms based on the LANSS pain scale
4. To compare patient distress between the two arms based on National Comprehensive Cancer Network (NCCN) Distress Thermometer (timepoint: end of run in period (prior to randomisation) and day 0, 4, 8, 12 and 16 of assessment period)
5. To assess the side-effects and tolerability of trial drug
6. To assess the effect of intervention on quality of life scores (based on Euroqol thermometer), anxiety and depression (based on Hospital Anxiety and Depression Scale [HADS]) and opioid requirements (timepoint: prior to randomisation, day 0, 4, 8, 12 and 16 of assessment period)
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Secondary ID(s)
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KPS 2006-001
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NCT01316744
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Source(s) of Monetary Support
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Cancer Research UK (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) (ref: C17958/A8689)
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