Evaluation of Chemotherapy Induced Neuropathy in Solid Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- NOX4 Gene Expression in Blood of Solid Cancer Patients Undergoing Chemotherapy
研究概览
简要总结
The purpose of this prospective study is to perform Nerve conduction test, Vitamin D, Vitamin B12 and NADPH oxidase 4(NOX4) expression to assess severity of chemotherapy induced Peripheral neuropathy (CIPN) in solid cancer (Head and Neck, Breast, Prostate) patients who planned for at least 4 cycle of chemotherapy in different nutrient status level and gene expression.
详细描述
A)Screening of neuropathy in Healthy subject and Solid cancer patient before receiving chemotherapy & after 4th cycle of chemotherapy Patient who will be included in this study undergo complete neurological examination by using Total neuropathy score clinical version and Nerve conduction velocity test at baseline (0-cycle). Patients with no signs and symptoms of neuropathy will be recruited for the study. They will be followed up during the course of treatment and will undergo complete neurological examination by Total neuropathy score clinical version and nerve conduction velocity test will be done at 4th cycle to detect CIPN. Severity of CIPN will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
B)Estimation of 1,25-dihydroxyvitamin-D and Homocysteine level in all groups at baseline & 4th cycle 10,16 Approximately five millilitre of peripheral venous blood will be collected from each patient in anticoagulant (Acid-citrate-dextrose A) and centrifuge at 2500 RPM for 5 minutes. The plasma will be transferred to another tube remaining cell content will be discarded &the plasma will be stored at -20 degree Celsius.
The estimation of Concentration 1, 25-hydroxyvitamin-D and Homocysteine using CLIA.
The entire sample will be analysed following quality control analysis to eliminate error.
C) Measurement of NOX4 gene expression by RT-PCR (Real Time Polymerase Chain Reaction) analysis in all groups at baseline & 4th cycle
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients receiving chemotherapy for solid cancer
- •Patient aged>18years
排除标准
- •Age ≤ 18 years
- •Pre-existing neuropathy
- •Patients diagnosed with Psychiatric illness
- •Patients with pre-existing peripheral neuropathy
- •Patients taking medication for neuropathy
- •Long standing diabetes (>10 years)
- •Renal and Hepatic disease
研究组 & 干预措施
Baseline and after 4th cycle
Histopathologically diagnosed Solid Cancer Patients Planned for Platinum and Taxane based chemotherapy will be going for Neuropathy test- Nerve conduction test(NCV), vitamin D, B12 and Nox4 expression at Baseline and after 4th cycle of chemo
干预措施: Cisplatin, Carboplatin, Paclitaxel, Docetaxel (Drug)
结局指标
主要结局
NOX4 Gene Expression in Blood of Solid Cancer Patients Undergoing Chemotherapy
时间窗: at Baseline and after 4th cycle of chemotherapy (3weekly cycle) 84 days
The expression level of the NADPH oxidase 4 (NOX4) gene in blood will be measured using real time polymerase chain reaction (RT-PCR) to assess its potential role in chemotherapy-induced neuropathy. Ct-value of Nox4 gene will be normalized with reference gene GAPDH to calculate relative expression using 2-∆∆Ct method. Changes in NOX4 expression will be analyzed to understand its relationship with neuropathy development in solid cancer patients undergoing chemotherapy. Blood samples will be collected at baseline and after the fourth cycle of chemotherapy
Assessment of different type and severity of Neuropathy in Solid Cancer Patients Undergoing Chemotherapy using Total Neuropathy Score(TNS) and Nerve conduction velocity study
时间窗: Baseline and after 4th cycle of chemotherapy ( 3weekly cycle) 84 days
Sensory symptoms, Motor Symptoms, Pin sensation, Vibration sensibility, Strength, Tendon reflexes will be recording using likert scale from 0 to 5 "0= None, 1= Limited to fingers or toes, 2= Extend to ankle or wrist, 3= Extend to knee or elbow, 4= Above knees/elbows".
Serum Vitamin D and Homocysteine Levels in Solid Cancer Patients Undergoing Chemotherapy
时间窗: at baseline and after 4th cycle of chemotherapy ( 3weekly cycle) 84 days
Serum levels of vitamin D and homocysteine will be measured using chemiluminescent immunoassay (CLIA) techniques to evaluate their potential association with chemotherapy-induced neuropathy. Vitamin D plays a role in nerve health, while elevated homocysteine levels have been linked to nerve damage. These biomarkers will be assessed to explore their correlation with neuropathy symptoms. Blood samples for vitamin D and homocysteine levels will be collected at baseline and after the fourth cycle of chemotherapy.
serum catalase and malondialdehyde level in solid cancer patients undergoing chemotherapy
时间窗: at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days)
Catalase and Malondialdehyde will be measured using Enzyme linked immunosorbent assay (ELISA) to determine oxidative stress status.
Nerve conduction studies (NCS)
时间窗: at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days)
* Sensory nerve studies: Median and ulnar nerve measurements like the amplitude (mV), conduction velocity (m/s) and distal latency (ms) will be recorded at wrist and interpretation will be done as demyelination when amplitude decreases or normal, velocity- decreases and Latency-increases; Axonal when amplitude-decreased, conduction velocity-normal and latency normal * Motor nerve studies: Median and ulnar nerve measurements like the amplitude (mV), conduction velocity (m/s) and distal latency (ms) will be recorded at wrist and elbow and interpretation will be done as demyelination when amplitude decreases or normal, velocity- decreases and Latency-increases; Axonal when amplitude-decreased, conduction velocity-normal and latency normal
次要结局
- Measures peripheral neuropathy grade and quality of life using EORTC-QLQ-CIPN20(at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days))
研究者
Nabin Yadav
Principal Investigator
Swami Rama Himalayan University