A Study of the Efficacy and Safety of PerOx Quench on the Prevention of Oxaliplatin Treatment Induced Neuropathy

Study Overview
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Brief Summary
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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.

Detailed Description
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This study uses two stage group-sequential sampling design, based on current data, assumed the CIPN incidence rate is 50% in placebo arm, while 20% in PerOx Quench arm（60% reduction）, set a=0.05，80％ power, random allocation ratio is 1:1, obtained the subjects number is 41（total 82) by PASS 11 software for superior design; considering 10% drop out rate, final number of subjects totally is 90.

Official Title
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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

Conditions
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Colorectal Cancer, Advanced Gastric Cancer, Neuropathy

Intervention / Treatment
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* Dietary Supplement: PerOx Quench
* Dietary Supplement: PerOx Quench Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PerOx Arm<br>PerOx Quench arm 4g/sachet each time by water, q6h | Dietary Supplement: PerOx Quench<br>* By 1 week pretreatment of PerOx Quench and following 4 weeks taken to decrease the CIPN incidence.<br>|
| Placebo Comparator: Comparative Arm<br>PerOx Quench placebo 4g/sachet each time by water, q6h | Dietary Supplement: PerOx Quench Placebo<br>* By 1 week pretreatment of Placebo and following 4 weeks taken to record the CIPN incidence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Oxaliplatin-induced Peripheral Neuropathy incidence rate on the 35 day in 2 arms. | Peripheral neuropathy incidence rate was measured by frequency and percentage of any Oxaliplatin-induced Peripheral Neuropathy symptoms. | 35 day after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by PI on the 35 day in 2 arms. | 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. | 35 day after randomization | 
| Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by subjects on the 35 day in 2 arms. | Peripheral neuropathy severity by subjects was measured by Visual Analogue Scale (VAS) score (Scores range from 0 [no symptom] to 10 [worst possible symptom]). | 35 day after randomization | 
| Evaluation of subjects quality of life difference in 2 arms on the 35 day. | Quality of Life (QoL) will be measured by European Organization for Research and Treatment of Cancer quality of life questionaire C30 (EORTCQLQ-C30) questionnaire. | 35 day after randomization | 
| Evaluation of subjects Eastern Cooperation Oncology Group-Performance Score (ECOG-PS) difference in 2 arms on the 35 day. | Eastern Cooperation Oncology Group-Performance Score (ECOG-PS) will be measured by ECOG-PS score. | 35 day after randomization | 
| Evaluation of the Adverse Events (AEs) incidence rate on 35 day in 2 arms. | 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. | Sign ICF to 35 day after randomization |