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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 |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN49116945 |
| Date ISRCTN assigned | 27/04/2007 |
| Local reference number(s) | KPS 2006-001 |
| Public title | A randomised double-blind controlled trial of s-ketamine versus placebo in conjunction with best pain management in neuropathic pain in cancer patients |
| Scientific title | |
| Acronym | KPS (Ketamine in Pain Study) |
| Disease/condition/study domain | Neuropathic pain in cancer patients |
| Study hypothesis | 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. |
| Design/methodology | A randomised double blind design will be applied with both arms receiving standard best pain management. |
| Research ethics review | This protocol has yet to be submitted for ethical consideration. It will require approval by the Multi-Centre Research Ethics Committee (MREC) to which it is assigned. Site specific approval (SSA) must be obtained for all participating centres. The study will be carried out in agreement with the ¿Declaration of Helsinki¿ amended in Tokyo, Venice, Hong Kong, Edinburgh with revisions in Washington (2002) and Tokyo (2004). |
| Countries of trial | United Kingdom |
| Participants - 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) |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/06/2007 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Ongoing |
| Target number of participants | 214 |
| Interventions | 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. |
| Primary outcome measure(s) | 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. |
| Secondary outcome measure(s) | 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) |
| Sources of funding | Cancer Research UK (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) (ref: C17958/A8689) |
| Sponsor name | Greater Glasgow and Clyde Health Board/Glasgow University (UK) |
| Sponsor details | NHS North Glasgow University Hospitals Division West R & D Office, Administration Building Ground Floor, Room 9 Western Infirmary Glasgow United Kingdom G11 6NT |
| Sponsor website | http://www.nhsgg.org.uk/content/ |
| Contact name | Dr Marie Fallon |
| Contact details | Palliative Medicine/Oncology Edinburgh Cancer Centre University of Edinburgh Western General Hospital Crewe Road Edinburgh United Kingdom EH4 2 XU |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN49116945 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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