Observational and Data Collection Study About Intrathecal Ziconotide in the Treatment of Chemotherapy Induced Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Assess whether or not patients' pain score from VAS changes when receiving intrathecal ziconotide
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Assess whether or not patients' pain score from VAS changes when receiving intrathecal ziconotide
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Christopher Beuer, MD
Medical Director- Pain Management/Principal Investigator
Christian Hospital Northeast Northwest