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

NCT02560740 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-12-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

PerOx Quench

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

DIETARY_SUPPLEMENT

PerOx Quench Placebo

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

Sponsors & Collaborators

  • SMR Biotech Co., Ltd.

    lead OTHER

Principal Investigators

  • Jiejun WANG, MD., Ph.D · Shanghai Changzheng Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02560740 on ClinicalTrials.gov