Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
United States24 participantsStarted 2026-05-02
Plain-language summary
The purpose of this observational, data collection, research is to evaluate if ziconotide, a commercially approved medication given by a FDA cleared intrathecal pump, for chronic pain is effective in the treatment of chemotherapy-induced peripheral neuropathy (CIPN) a common and often long-lasting side effect of cancer treatment.
Who can participate
Age range
18 Years – 100 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.
Inclusion Criteria:
* Adult patients, ages 18-100, with chemotherapy-induced peripheral neuropathy as a primary source of pain
* The patient is already scheduled to be treated with TDD using ziconotide (no reported allergies to ziconotide or drug-drug interactions expected)
* Patient will have, or is scheduled to have, Medtronic Synchromed Intrathecal Pump implanted by Dr. Beuer (outside of the research)
* Patients already taking nonopioid analgesics will be allowed to continue their prescribed medication regimen.
* Patients currently taking opioid analgesics must undergo a washout period of 2 weeks (prior to device implant) before participating in this study. Those unable to adhere to this washout period will be excluded
Exclusion Criteria:
* Patients with other forms of neuropathy (diabetic, idiopathic) will be excluded
* Patients with a spinal cord stimulator will be excluded
* Patients with contraindications to intrathecal ziconotide will be excluded
* Patients who cannot sign the consent, participate in research activities, or those who require a legally authorized representative (LAR) will be excluded
* Patients who are pregnant and/or nursing or planning to become pregnant are excluded
* Also excluded are those inaccessible for follow-up, participation is excluded by local law, or a patient is currently enrolled or plans to enroll in a concurrent drug/device study
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
1
Assess whether or not patients' pain score from VAS changes when receiving intrathecal ziconotide
Timeframe: From enrollment to the end of treatment at 24 months
2
Assess whether or not patients' answers to ODI change when receiving intrathecal ziconotide
Timeframe: From enrollment to the end of treatment at 24 months
3
Assess whether or not patients' answers to PROMIS change when receiving intrathecal ziconotide
Timeframe: From enrollment to the end of treatment at 24 months