UnknownPhase 3

Ketamine Hydrochloride and Best Pain Management in Treating Cancer Patients With Neuropathic Pain

United Kingdom214 participantsStarted 2009-04

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to treatment failure

Trial details

NCT IDNCT01316744

SponsorUniversity of Glasgow

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-10

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