Christian Hospital
St Louis, Missouri, 63136, United States
Location contact
Cassandra Wania, BSN
CONTACT
Christopher L Beuer, MD
PRINCIPAL_INVESTIGATOR
Maksim Shoykhet, BSN
CONTACT
NCT Number: NCT07499882
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.
Trial opening soon.
Get Notified18 year–100 year
All sexes
Observational
St Louis, Missouri, 63136, United States
Cassandra Wania, BSN
CONTACT
Christopher L Beuer, MD
PRINCIPAL_INVESTIGATOR
Maksim Shoykhet, BSN
CONTACT
Chemotherapy-induced peripheral neuropathy is a painful condition that significantly impacts quality of life following a patient's cancer treatment. This condition is often irreversible and fails to respond well to commonly utilized medications (most frequently Gabapentin, Lyrica, and Cymbalta) (Piccolo & Kolesar, 2014). While spinal cord stimulation is approved for the treatment of painful diabetic neuropathy, it is not approved for the treatment of chemotherapy-induced neuropathy. This often leaves a void in treatment options for those not responding to topical treatments or oral medications. Data from prior clinical studies have shown targeted drug delivery (TDD), using an implanted Medtronic Synchromed Intrathecal Pain Pump, has successfully treated patients with chemotherapy-induced peripheral neuropathy using opioids such as morphine (Potocnik et al., 2025). However, no study as of yet has focused on the potential role ziconotide, a non-opioid treatment given intrathecally, may play in the pain management of these patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Real world evidence trial. Patients that are on intrathecal ziconotide will be observed for two years, to determine whether or not this drug is effective for chemotherapy induced peripheral neuropathy.
Time frame: From enrollment to the end of treatment at 24 months
One primary objective of this observational study is to obtain data to assess the information collected from the Visual Analog Scale (VAS) in patients with chemotherapy-induced peripheral neuropathy after treatment with intrathecal ziconotide, over a 24-month period.
Time frame: From enrollment to the end of treatment at 24 months
One primary objective of this observational study is to obtain data to assess the information collected from the Oswestry Disability Index (ODI) in patients with chemotherapy-induced peripheral neuropathy after treatment with intrathecal ziconotide, over a 24-month period.
Time frame: From enrollment to the end of treatment at 24 months
One primary objective of this observational study is to obtain data to assess the information collected from the Patient Reported Outcomes Measurement Information System (PROMIS) in patients with chemotherapy-induced peripheral neuropathy after treatment with intrathecal ziconotide, over a 24-month period.
Contact information is provided by the study sponsor or research team.
Cassandra Wania, BSN
CONTACT
Maksim Shoykhet, BSN
CONTACT
Christian Hospital Northeast Northwest
Other
Observational and Data Collection Study About Intrathecal Ziconotide in the Treatment of Chemotherapy Induced Neuropathy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07508527
Balance, Chemotherapy Induced Peripheral Neuropathy (CIPN)
View Trial DetailsNCT07368439
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT07346469
Chemotherapy Induced Peripheral Neuropathy (CIPN), Colonic Diseases
Kaohsiung City, Sanmin District, Taiwan
View Trial DetailsNCT07319481
Chemotherapy Induced Peripheral Neuropathy (CIPN), Hematologic Diseases
Zhengzhou, China
View Trial Details