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

NCT ID: NCT02560740

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-11-30

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.

Conditions

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Colorectal Cancer Advanced Gastric Cancer Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PerOx Arm

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

Group Type EXPERIMENTAL

PerOx Quench

Intervention Type DIETARY_SUPPLEMENT

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

Comparative Arm

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

Group Type PLACEBO_COMPARATOR

PerOx Quench Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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PerOx Quench

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

Intervention Type DIETARY_SUPPLEMENT

PerOx Quench Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SMR Biotech Co., Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiejun WANG, MD., Ph.D

Role: STUDY_DIRECTOR

Shanghai Changzheng Hospital

Locations

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Shanghai Changzheng hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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POQ 00001

Identifier Type: -

Identifier Source: org_study_id