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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN49116945

Enrollment

214

Registered

2007-04-27

Start date

2009-04-24

Completion date

Unknown

Last updated

2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic pain in cancer patients Cancer Neuropathic pain in cancer patients

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026