Intravenous Lidocaine Infusion Versus Oral Duloxetine For The Prevention And Treatment Of Chemotherapy Induced Peripheral Neuropathy Among Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Neuropathic pain characters and severity
研究概览
简要总结
The aim of the study is to evaluate the effect of intravenous (IV) lidocaine versus oral duloxetine on the onset and severity of TIPN in patient with breast cancer as well as evaluation of Patients' quality of life and estimation the cell mediated immunity.
The current study is a single blinded randomized controlled study, assumed that lidocaine could prevent and reduce TIPN similar to duloxetine in patient with breast cancer.
Method of randomization: The allocation sequence was generated using permuted block randomization technique and the block size was variable. Allocation sequence/code was concealed from the person allocating the participants to the intervention arms using sealed opaque envelopes.
Primary outcome: Degree of neuropathic pain measured by neuropathy pain scale (NPS) among breast cancer patients on Taxane chemotherapy after the pretreatment with either lidocaine or duloxetine.
Secondary outcomes are: The incidence of TIPN using DN4 questionnaire and nerve conduction study and Patients' quality of life using The European Organization for Research and Treatment of Cancer (EORTC) QLQ-CIPN20 as well as the Change in serum level natural killer cell to estimate cell mediated immunity.
详细描述
Patients' assessment:
- Medical history (Previous diseases and medications)
- Clinical examination and laboratory investigations (according to patient' condition).
- Each patient will be informed with the study, its expected result and its possible side effects. The patients will be trained to use neuropathic pain scale (NPS). Additionally, DN4 questionnaire will be explained to all participants. IV line will be inserted for all participants. Vital signs including heart rate and mean arterial blood pressure will be measured.
The participants will be randomly allocated into three groups as follows:
- Group control (C): 20 adult breast cancer patients on Taxane chemo protocol will receive 200 ml normal saline over forty minutes pre each chemotherapy session until end of the cycle.
- Group lidocaine infusion (L): 20 adult breast cancer patients on Taxane chemo protocol will receive lidocaine IV infusion (2 mg/kg) in 200ml saline over forty minutes with a maximum upper limit of 200 mg pre each chemotherapy session until end of the cycle. If any selected patient reported neuropathic pain (DN4 > 4) during the course of chemotherapy lidocaine (2 mg/kg) re-infused after each session. If lidocaine side effects such as circumoral numbness, twitches, metal test, tachy or bradycardia recorded at any time, lidocaine infusion will be reduced to 1mg/kg, if side effects persist, the patients will be managed accordingly as well as lidocaine infusion will be stopped and patient will be excluded from the study.
- Group duloxetine (D): 20 adult breast cancer patients on chemotherapy will take oral duloxetine tablet 30 mg once per day starting from the night pre chemotherapy session until the end of cycle. If any selected patient reported neuropathic pain (DN4 > 4) during the course of chemotherapy the duloxetine dose will be adjusted to 60 mg daily till the end of the cycle. They also will receive 200 ml normal saline over forty minutes before each chemotherapy session until end of the cycle.
Measurements
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast cancer
- •at any stage,
- •Taxane chemo-protocol.
排除标准
- •Documented history of gloves and stock neuropathy.
- •Alcohol abuse.
- •Abnormal renal or liver function tests.
- •Allergy to local anesthetics.
- •Myocardial infarction within 6 months
- •Profound high-grade arrhythmias.
- •Patients with neurological or psychological problems.
- •Diabetes Mellitus.
- •History of previous chemotherapy treatment
研究组 & 干预措施
Group Control (C)
20 adult breast cancer patients on Taxane chemo protocol will receive 200 ml normal saline over forty minutes pre each chemotherapy session until end of the cycle.
干预措施: Normal saline (Drug)
Group lidocaine infusion (L)
20 adult breast cancer patients on Taxane chemo protocol will receive lidocaine i.v infusion (2 mg/kg) in 200ml saline over forty minutes with a maximum upper limit of 200 mg pre each chemotherapy session until end of the cycle. If any selected patient reported neuropathic pain (DN4 > 4) during the course of chemotherapy lidocaine (2 mg/kg) re-infused after each session. If lidocaine side effects such as circumoral numbness, twitches, metal test, tachy or bradycardia recorded at any time, lidocaine infusion will be reduced to 1mg/kg, if side effects persist, the patients will be managed accordingly as well as lidocaine infusion will be stopped and patient will be excluded from the study.
干预措施: Lidocaine in Saline (Drug)
Group duloxetine (D)
20 adult breast cancer patients on chemotherapy will take oral duloxetine tablet 30 mg once per day starting from the night pre chemotherapy session until the end of cycle. If any selected patient reported neuropathic pain (DN4 > 4) during the course of chemotherapy the duloxetine dose will be adjusted to 60 mg daily till the end of the cycle. They also will receive 200 ml normal saline over forty minutes before each chemotherapy session until end of the cycle.
干预措施: Duloxetine 30 MG (Drug)
结局指标
主要结局
Change in Neuropathic pain characters and severity
时间窗: every week for 12 weeks (after each chemotherapy session)
The change in intensity and characters of neuropathic pain will be measured using Neuropathy Pain Scale (NPS). It quantifies severity of neuropathic pain (0 indicates no pain, 10 indicates the most pain imaginable).
次要结局
- Quality of life assessment using the European Organization for Research and Treatment of Cancer - Quality of life questioner - Chemotherapy induced peripheral neuropathy twenty-item scale(EORTC - QLQ - CIPN20 ).(Baseline (before starting chemotherapy protocol), one month ,two month and at 12 weeks ( end of chemotherapy cycle))
- Detection of Chemotherapy induced peripheral neuropathy using sensory nerve conduction latency study .(Baseline (before starting chemotherapy protocol) then 12 weeks later ( end of chemotherapy cycle))
- Detection of Chemotherapy induced peripheral neuropathy using sensory nerve conduction amplitude study .(Baseline (before starting chemotherapy protocol) then 12 weeks later ( end of chemotherapy cycle))
- Detection of Chemotherapy induced peripheral neuropathy using sensory nerve conduction velocity study .(Baseline (before starting chemotherapy protocol) then 12 weeks later ( end of chemotherapy cycle))
- Incidence of Taxane induced peripheral neuropathy (TIPN) using Douleur Neuropathique 4 questionnaire (DN4)(Baseline (before starting chemotherapy protocol), then every week for 12 weeks (after each chemotherapy session))
- Change in serum level of natural killer cell to estimate cell mediated immunity(Baseline (before starting chemotherapy protocol) then 12 weeks later ( end of chemotherapy cycle))
研究者
Gamal Mohamed Taha Abouelmagd
MSc Anaesthesia and Surgical Intensive Care
Alexandria University