Condition category
Cancer
Date applied
12/04/2007
Date assigned
27/04/2007
Last edited
14/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Marie Fallon

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01316744

Protocol/serial number

KPS 2006-001

Study information

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

Acronym

KPS (Ketamine in Pain Study)

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.

Ethics approval

West of Scotland Research Ethics Committee (1), 02/07/2008, ref: 08/S0703/103

Study design

Randomised double-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

S-ketamine

Primary outcome measures

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 measures

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)

Overall trial start date

01/06/2007

Overall trial end date

29/04/2014

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

214

Participant 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

Recruitment start date

24/04/2009

Recruitment end date

29/04/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Edinburgh Cancer Centre
Edinburgh
EH4 2 XU
United Kingdom

Sponsor information

Organisation

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
G11 6NT
United Kingdom

Sponsor type

Government

Website

http://www.nhsgg.org.uk/content/

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes