Clinical trial · Interventional
Ketamine Hydrochloride and Best Pain Management in Treating Cancer Patients With Neuropathic Pain
A Randomized Double-Blind Controlled Trial of Ketamine Versus Placebo in Conjunction With Best Pain Management in Neuropathic Pain in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Ketamine hydrochloride may lessen neuropathic pain in patients with cancer. It is not yet known whether ketamine hydrochloride given together with the best pain management is more effective than a placebo given together with the best pain management in treating neuropathic pain in patients with cancer. PURPOSE: This randomized phase III trial is studying ketamine hydrochloride given together with the best pain management to see how well it works compared with giving a placebo together with the best pain management in treating cancer patients with neuropathic pain.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| ketamine hydrochloride | Drug | — | UNRESOLVED |
| pharmacogenomic studies | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to treatment failure
Secondary outcomes (7)
- measure
- Initial treatment benefit (at day 4 of assessment period of 16 days) using the sensory component of the McGill Short-Form Questionnaire
- measure
- Difference in overall pain between the study arms based on the visual-analogue score
- measure
- Difference in neuropathic pain between the study arms based on the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
- measure
- Worst pain score (index neuropathic site) in the previous 24 hours (between the two arms) at study baseline and then during study assessment period
- measure
- Patient distress between the two arms based on NCCN Distress Thermometer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed cancer * Index neuropathic pain ≥ 4 on 0-10 (as defined by Leeds Assessment of Neuropathic Symptoms and Signs) that is related to underlying malignancy or resulting from treatment received for this malignancy * McGill Sensory Scale Score \> 5 * Received a trial of an adjuvant analgesic (gabapentin or amitriptyline or both) PATIENT CHARACTERISTICS: * Life expectancy ≥ 2 months * Fertile patients must use effective contraception * Able to comply with study procedures * Diastolic blood pressure ≤ 100 mm Hg at screening * No seizures in past 2 years * Not actively hallucinating * No cerebrovascular disease (strokes) * No psychotic disorders or cognitive impairment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 6 weeks since prior and no concurrent chemotherapy or radiotherapy that is likely to affect neuropathic pain * No change in tumoricidal treatment during the period of the study that is likely to alter pain during the course of the study * No concurrent class I antiarrhythmic drugs
References
Publications (0)
Data not yet available