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

NCT02560740 | Terminated

• 1 other identifier: POQ 00001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer; Advanced Gastric Cancer; Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by PI on the 35 day in 2 arms.

  35 day after randomization

• Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by subjects on the 35 day in 2 arms.

  35 day after randomization

• Evaluation of subjects quality of life difference in 2 arms on the 35 day.

  35 day after randomization

• Evaluation of subjects Eastern Cooperation Oncology Group-Performance Score (ECOG-PS) difference in 2 arms on the 35 day.

  35 day after randomization

• Evaluation of the Adverse Events (AEs) incidence rate on 35 day in 2 arms.

  Sign ICF to 35 day after randomization

Study Arms (2)

PerOx Arm

EXPERIMENTAL

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

Dietary Supplement: PerOx Quench

Comparative Arm

PLACEBO COMPARATOR

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

Dietary Supplement: PerOx Quench Placebo

Interventions

PerOx Quench DIETARY_SUPPLEMENT

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

PerOx Arm

PerOx Quench Placebo DIETARY_SUPPLEMENT

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

Comparative Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SMR Biotech Co., Ltd.: lead

Study Sites (1)

Shanghai Changzheng hospital

Shanghai, Shanghai Municipality, 200003, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jiejun WANG, MD., Ph.D

  Shanghai Changzheng Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2015
• First Posted: September 25, 2015
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 14, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)