Chemotherapy Induced Peripheral Neuropathy (CIPN)
Conditions
Keywords
intrathecal pump, ziconotide, chronic pain, targeted drug delivery, neuropathy, cipn, chemotherapy induced neuropathy, neuropathy after cancer treatment
Brief 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.
Detailed description
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.
Interventions
DRUGZiconotide
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.
Sponsors
Christian Hospital Northeast Northwest
TerSera Therapeutics LLC
TeamHealth
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess whether or not patients' pain score from VAS changes when receiving intrathecal ziconotide | 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. |
| Assess whether or not patients' answers to ODI change when receiving intrathecal ziconotide | 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. |
| Assess whether or not patients' answers to PROMIS change when receiving intrathecal ziconotide | 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. |
Countries
United States
Contacts
CONTACTMaksim Shoykhet, BSN
CONTACTCassandra Wania, BSN
PRINCIPAL_INVESTIGATORChristopher L Beuer, MD
BJC TeamHealth
Outcome results
None listed