A Study of the Efficacy and Safety of PerOx Quench on the Prevention of Oxaliplatin Treatment Induced Neuropathy
A Randomised, Double-blinded, Placebo Controlled Study to Assess the Efficacy and Safety of PerOx Quench or Placebo for 35 Days on the Prevention of Oxaliplatin Treatment Induced Sensory Neuropathy
Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and often irreversible condition featuring pain, numbness, tingling and sensitivity to cold in the hands and feet (sometimes progressing to the arms and legs) that afflicts between 30 and 40 percent of patients undergoing chemotherapy.
American Society of Clinical Oncology (ASCO) guidance on The Journal of Clinical Oncology (JCO, 2014 April 14) does not recommend any prophylaxis regimen for CIPN.
PerOx Quench has unique membrane protection and anti-oxidative function as a special food, that's why to try to explore its preventive effects on CIPN prevention induced by Oxaliplatin for colorectal cancer or gastric cancer chemotherapy.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
Shanghai
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Shanghai、Shanghai、中国、200003
- Shanghai Changzheng Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age between 18-80 years old, male and female
- Without anti-cancer treatment before randomization, ECOG score 0-2
- Estimate to bear at least 4 cycles chemotherapy treatment with normal function of heart, lungs, liver and kidneys.
- Survival expectation ≥6 months
- Signed Informed Consent Form, willing to follow all study procedures
Exclusion Criteria:
- Received chemotherapy treatment within 4 weeks before randomization.
- Current peripheral neuropathy(by chemotherapy, diabetes mellitus, alcoholic disease) and relative symptoms with relevant treatment.
- Concurrent treatment within 30 days after randomization with the following drugs: Calcium-Magnesium injection, glutathione, and similar ingredients with PerOx Quench (such as polyene phosphatidyl choline).
Laboratory tests found not suitable for chemotherapy patients (Absolute neutrophil count <2.0×10*9/L<2,000/mm3>; or platelet count<100× 10*9/L<100,000/mm3>; or hemoglobin <10/dl; or serum total bilirubin >2 Upper Limit Of Normal (ULN), alanine aminotransferase (ALT)/aspartate aminotransferase (AST)>3 Upper Limit Of Normal (ULN); or serum creatinine >1.5 Upper Limit Of Normal (ULN) <or creatinine clearance rate
≤60ml/min>）.
- Pregnancy, lactation and reluctant to using contraception women.
- Patients with symptomatic brain metastases and other mental disorders could not be self assessment.
- Alcohol and/or drug abuse or doctors determine compliance's claim.
- Within a month in other clinical trial subjects.
- Once into the group of this study, or random within eight weeks before using this product.
- personnel involved this study.
- Not completed independent self assessment of patients.
- Other researchers determine does not fit to participate in this study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：PerOx Arm
PerOx Quench arm 4g/sachet each time by water, q6h
|
By 1 week pretreatment of PerOx Quench and following 4 weeks taken to decrease the CIPN incidence.
|
|
安慰剂比较：Comparative Arm
PerOx Quench placebo 4g/sachet each time by water, q6h
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By 1 week pretreatment of Placebo and following 4 weeks taken to record the CIPN incidence.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of Oxaliplatin-induced Peripheral Neuropathy incidence rate on the 35 day in 2 arms.
大体时间：35 day after randomization
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Peripheral neuropathy incidence rate was measured by frequency and percentage of any Oxaliplatin-induced Peripheral Neuropathy symptoms.
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35 day after randomization
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by PI on the 35 day in 2 arms.
大体时间：35 day after randomization
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Peripheral neuropathy severity by PI was measured by each related symptom grading, and the most serious symptom will be evaluated by National Cancer Institute Common Toxicity Criteria (NCI-CTC) classification.
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35 day after randomization
|
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Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by subjects on the 35 day in 2 arms.
大体时间：35 day after randomization
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Peripheral neuropathy severity by subjects was measured by Visual Analogue Scale (VAS) score (Scores range from 0 [no symptom] to 10 [worst possible symptom]).
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35 day after randomization
|
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Evaluation of subjects quality of life difference in 2 arms on the 35 day.
大体时间：35 day after randomization
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Quality of Life (QoL) will be measured by European Organization for Research and Treatment of Cancer quality of life questionaire C30 (EORTCQLQ-C30) questionnaire.
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35 day after randomization
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Evaluation of subjects Eastern Cooperation Oncology Group-Performance Score (ECOG-PS) difference in 2 arms on the 35 day.
大体时间：35 day after randomization
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Eastern Cooperation Oncology Group-Performance Score (ECOG-PS) will be measured by ECOG-PS score.
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35 day after randomization
|
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Evaluation of the Adverse Events (AEs) incidence rate on 35 day in 2 arms.
大体时间：Sign ICF to 35 day after randomization
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The Adverse Events (AEs) incidence rate was measured by frequency and percentage of participants with Treatment-Related Grade 3 or above Adverse Events during this trial.
The grade of Adverse Events was assessed by Common Toxicity Criteria Adverse Event (CTCAE) v4.0.
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Sign ICF to 35 day after randomization
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合作者和调查者
调查人员
- 研究主任：Jiejun WANG, MD., Ph.D、Shanghai Changzheng Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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