A randomised double-blind controlled trial of s-ketamine versus placebo in conjunction with best pain management in neuropathic pain in cancer patients

ISRCTN	ISRCTN49116945
DOI	https://doi.org/10.1186/ISRCTN49116945
ClinicalTrials.gov (NCT)	NCT01316744
Protocol serial number	KPS 2006-001
Sponsor	Greater Glasgow and Clyde Health Board/Glasgow University (UK)
Funder	Cancer Research UK

Submission date: 12/04/2007
Registration date: 27/04/2007
Last edited: 25/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/study-anaesthetic-treat-cancer-related-nerve-pain

Contact information

Dr Marie Fallon
Scientific

Palliative Medicine/Oncology
Edinburgh Cancer Centre
University of Edinburgh
Western General Hospital
Crewe Road
Edinburgh
EH4 2 XU
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised double-blind trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised double-blind controlled trial of s-ketamine versus placebo in conjunction with best pain management in neuropathic pain in cancer patients
Study acronym	KPS (Ketamine in Pain Study)
Study objectives	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.
Ethics approval(s)	West of Scotland Research Ethics Committee (1), 02/07/2008, ref: 08/S0703/103
Health condition(s) or problem(s) studied	Neuropathic pain in cancer patients
Intervention	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.
Intervention type	Drug
Phase	Phase III
Drug / device / biological / vaccine name(s)	S-ketamine
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.
Key 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)
Completion date	29/04/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	214
Total final enrolment	214
Key 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)
Key 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
Date of first enrolment	24/04/2009
Date of final enrolment	29/04/2014

Locations

Countries of recruitment

United Kingdom

Study participating centre

Edinburgh Cancer Centre

Edinburgh
EH4 2 XU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2018	18/02/2019	Yes	No
Plain English results			25/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
18/02/2019: Publication reference added.
07/07/2017: No publications found in PubMed, verifying study status with principal investigator.