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.

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.

Inclusion Criteria:

1. Age between 18-80 years old, male and female
2. Without anti-cancer treatment before randomization, ECOG score 0-2
3. Estimate to bear at least 4 cycles chemotherapy treatment with normal function of heart, lungs, liver and kidneys.
4. Survival expectation ≥6 months
5. Signed Informed Consent Form, willing to follow all study procedures

Exclusion Criteria:

1. Received chemotherapy treatment within 4 weeks before randomization.

2. Current peripheral neuropathy(by chemotherapy, diabetes mellitus, alcoholic disease) and relative symptoms with relevant treatment.

3. 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).

4. 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>）.

5. Pregnancy, lactation and reluctant to using contraception women.

6. Patients with symptomatic brain metastases and other mental disorders could not be self assessment.

7. Alcohol and/or drug abuse or doctors determine compliance's claim.

8. Within a month in other clinical trial subjects.

9. Once into the group of this study, or random within eight weeks before using this product.

10. personnel involved this study.

11. Not completed independent self assessment of patients.

12. Other researchers determine does not fit to participate in this study.