Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorChristian Hospital Northeast Northwest
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Adult patient, ages 18-100, with chemotherapy induced peripheral neuropathy that have not responded well to conservative measures
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Ziconotide
DrugReal 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.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Study group1 intervention
Trial outcomes
Primary outcomes
1
Assess whether or not patients' pain score from VAS changes when receiving intrathecal ziconotide
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 months2
Assess whether or not patients' answers to ODI change when receiving intrathecal ziconotide
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 months3
Assess whether or not patients' answers to PROMIS change when receiving intrathecal ziconotide
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.
Time frame
From enrollment to the end of treatment at 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Christian Hospital Northeast Northwest
Lead sponsor
TerSera Therapeutics LLC
Collaborator
TeamHealth
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: