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Oxaliplatin

PerOx Quench arm 4g/sachet each time by water, q6h

PerOx Quench placebo 4g/sachet each time by water, q6h

By 1 week pretreatment of PerOx Quench and following 4 weeks taken to decrease the CIPN incidence.

PerOx Quench

By 1 week pretreatment of Placebo and following 4 weeks taken to record the CIPN incidence.

PerOx Quench Placebo

Jiejun WANG, MD., Ph.D

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.

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

Peripheral neuropathy incidence rate was measured by frequency and percentage of any Oxaliplatin-induced Peripheral Neuropathy symptoms.

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.

Peripheral neuropathy severity by subjects was measured by Visual Analogue Scale (VAS) score (Scores range from 0 \[no symptom\] to 10 \[worst possible symptom\]).

Quality of Life (QoL) will be measured by European Organization for Research and Treatment of Cancer quality of life questionaire C30 (EORTCQLQ-C30) questionnaire.

Eastern Cooperation Oncology Group-Performance Score (ECOG-PS) will be measured by ECOG-PS score.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of the Efficacy and Safety of PerOx Quench on the Prevention of Oxaliplatin Treatment Induced Neuropathy	NCT02560740	Colorectal Canc... Advanced Gastri... Neuropathy	PerOx Quench PerOx Quench Pl...	18 Years - 80 Years	SMR Biotech Co., Ltd.
A Study of the Efficacy and Safety of PerOx Quench on the Prevention of Oxaliplatin Treatment Induced Neuropathy	NCT02560740	Colorectal Canc... Advanced Gastri... Neuropathy	PerOx Quench PerOx Quench Pl...	18 Years - 80 Years	SMR Biotech Co., Ltd.

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