Evaluation of Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Presence of change in Nerve Excitability in comparison to baseline nerve excitability.
研究概览
简要总结
This study aims to evaluate nerve excitability in participants with cisplatin-induced peripheral neuropathy (cis-PN) using threshold tracking nerve conduction studies (TTNCS). By assessing changes in nerve excitability parameters, the study seeks to enhance understanding of the pathophysiology of cis-PN and identify early markers of neurotoxicity in participants undergoing cisplatin-based chemotherapy.
详细描述
This study aims to evaluate nerve excitability in participants with cisplatin-induced peripheral neuropathy (cis-PN) using threshold tracking nerve conduction studies (TTNCS). By assessing changes in nerve excitability parameters, the study seeks to enhance understanding of the pathophysiology of cis-PN and identify early markers of neurotoxicity in participants undergoing cisplatin-based chemotherapy.
Peripheral neuropathy is a sensory disorder where patients feel a burning, tingling, or pins-and-needles sensation in the hands and feet that can lead to oversensitivity or numbness.
The U.S. Food and Drug Administration (FDA) has not approved DS5 0 Isolated Bipolar Constant Current Stimulator as a diagnostic tool for Peripheral Neuropathy.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, questionnaires, and standard neurological exams called nerve conduction studies and Threshold tracking nerve conduction studies.
Participants will be placed into one of the following groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age ≥ 18 who will begin cisplatin-based chemotherapy either alone or in combination with other agents that are not known to cause neuropathy.
- •Participants must have adequate hematologic parameters to allow chemotherapy.
排除标准
- •Pre-existing peripheral neuropathy;
- •Family history of a genetic/familial neuropathy;
- •Any contraindication for treatment with cisplatin as determined by their primary oncologist;
- •Chemotherapy regimen combining cisplatin with another known chemotherapy agent that may cause peripheral neuropathy;
- •Patients with cardiac or spinal stimulating devices;
- •Women who are pregnant or breastfeeding;
- •Adults with impaired consent capacity as patients must be able to fill out questionnaires regarding their neuropathy symptoms;
- •Other medical conditions that in the opinion of the treating physician would make the protocol unreasonably hazardous for the patient;
- •Patients not considered to be able to comply with the protocol.
- •Inclusion Criteria Cohort B:
- •Adults age ≥ 18 with a diagnosis of cis-PN.
- •The last dose of cisplatin must be ≥ 3 months prior to study enrollment. Patients who may have been previously enrolled in Cohort A of this study are eligible to participate in Cohort B if they continue to have cis-PN symptoms 3 months after completion of cisplatin therapy.
- •Exclusion Criteria Cohort B:
- •Pre-existing peripheral neuropathy;
- •Family history of a genetic/familiar neuropathy;
- •History of cisplatin-based regimen combining cisplatin with another known chemotherapy agent that may cause peripheral neuropathy;
- •Patients with cardiac or spinal stimulating devices;
- •Women who are pregnant or breastfeeding;
- •Adults with impaired consent capacity as patients must be able to fill out questionnaires regarding their neuropathy symptoms;
- •Other medical conditions that in the opinion of the treating physician would make the protocol unreasonably hazardous for the patient;
- •Patients not considered to be able to comply with the protocol.
研究组 & 干预措施
Cohort A: Participants Without Cisplatin-Induced Peripheral Neuropathy
30 participants with no baseline neuropathy symptoms will be enrolled prior to starting cisplatin-based chemotherapy and will complete the following:
- Baseline visit with neurological exams and conduction studies
- Standard of care chemotherapy infusion (duration may vary depending on the chemotherapy regimen received)
- Post-Infusion study visits via phone call (number of visits may vary depending on the chemotherapy regimen received)
- In-clinic visit with neurological exams and conduction studies if participants develop cis-PN symptoms
--If participants do not develop cis-PN symptoms, participants will be reevaluated 1 month post end of cisplatin treatment
- 7-day end of treatment visit via phone call
- 1-month post-treatment visit with neurological exams and conduction studies
干预措施: Threshold Tracking Nerve Conduction Studies (Diagnostic Test)
Cohort B: Participants with Cisplatin-Induced Peripheral Neuropathy
30 participants with cis-PN symptoms will be enrolled and will complete the following:
-One-time visit with neurological exams and conduction studies
干预措施: Threshold Tracking Nerve Conduction Studies (Diagnostic Test)
结局指标
主要结局
Presence of change in Nerve Excitability in comparison to baseline nerve excitability.
时间窗: For Arm A, the time frame is at baseline and within 24 weeks of cisplatin initiation. For Arm B, the time frame is during the TTNCS procedure.
Nerve excitability will be assessed via Threshold Tracking Nerve Conduction Study (TTNCS). Excitability parameters collected will include refractoriness, superexcitability, extent of threshold change in threshold electrotonus (hyperpolarizing 90-100ms). A composite excitability score is calculated to assess overall change in excitability parameters, all of which are weighted equally (Park, S.B., Lin, C.S.Y., Kiernan, M.C. Nerve Excitability Assessment in Chemotherapy-induced Neurotoxicity.J. Vis. Exp. (62), e3439, doi:10.3791/3439 (2012).
Presence of change in Nerve Excitability in comparison to baseline nerve excitability.
时间窗: For Arm A, the time frame is at baseline and within 24 weeks of cisplatin initiation. For Arm B, the time frame is during the TTNCS procedure.
Nerve excitability will be assessed via Threshold Tracking Nerve Conduction Study (TTNCS). Excitability parameters collected will include refractoriness, superexcitability, extent of threshold change in threshold electrotonus (hyperpolarizing 90-100ms). A composite excitability score is calculated to assess overall change in excitability parameters, all of which are weighted equally (Park, S.B., Lin, C.S.Y., Kiernan, M.C. Nerve Excitability Assessment in Chemotherapy-induced Neurotoxicity.J. Vis. Exp. (62), e3439, doi:10.3791/3439 (2012).
次要结局
- Number of participants who develop neuropathy symptoms as assessed by CTCAE v. 5.0.(For Arm A, peripheral neuropathy symptoms will be assessed at baseline and the time of the development of Cis-PN symptoms over the course of 24 weeks. For Arm B, symptoms will be assessed immediately before the TTNCS procedure.)
- Number of participants who develop neuropathy symptoms as assessed by CTCAE v. 5.0.(For Arm A, peripheral neuropathy symptoms will be assessed at baseline and the time of the development of Cis-PN symptoms over the course of 24 weeks. For Arm B, symptoms will be assessed immediately before the TTNCS procedure.)
研究者
Ka-Wai Ho
Sponsor-Investigator
Beth Israel Deaconess Medical Center