search
Back to results

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

Primary Purpose

Colorectal Cancer, Advanced Gastric Cancer, Neuropathy

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PerOx Quench
PerOx Quench Placebo
Sponsored by
SMR Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Changzheng hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PerOx Arm

Comparative Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by PI on the 35 day in 2 arms.
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.
Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by subjects on the 35 day in 2 arms.
Peripheral neuropathy severity by subjects was measured by Visual Analogue Scale (VAS) score (Scores range from 0 [no symptom] to 10 [worst possible symptom]).
Evaluation of subjects quality of life difference in 2 arms on the 35 day.
Quality of Life (QoL) will be measured by European Organization for Research and Treatment of Cancer quality of life questionaire C30 (EORTCQLQ-C30) questionnaire.
Evaluation of subjects Eastern Cooperation Oncology Group-Performance Score (ECOG-PS) difference in 2 arms on the 35 day.
Eastern Cooperation Oncology Group-Performance Score (ECOG-PS) will be measured by ECOG-PS score.
Evaluation of the Adverse Events (AEs) incidence rate on 35 day in 2 arms.
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.

Full Information

First Posted
August 15, 2015
Last Updated
December 13, 2016
Sponsor
SMR Biotech Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02560740
Brief Title
A Study of the Efficacy and Safety of PerOx Quench on the Prevention of Oxaliplatin Treatment Induced Neuropathy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Subjects' not-well compliance due to diarrhea and softening stool after taking PerOx Quench 4 sachets a day.
Study Start Date
March 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SMR Biotech Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Advanced Gastric Cancer, Neuropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PerOx Arm
Arm Type
Experimental
Arm Description
PerOx Quench arm 4g/sachet each time by water, q6h
Arm Title
Comparative Arm
Arm Type
Placebo Comparator
Arm Description
PerOx Quench placebo 4g/sachet each time by water, q6h
Intervention Type
Dietary Supplement
Intervention Name(s)
PerOx Quench
Intervention Description
By 1 week pretreatment of PerOx Quench and following 4 weeks taken to decrease the CIPN incidence.
Intervention Type
Dietary Supplement
Intervention Name(s)
PerOx Quench Placebo
Intervention Description
By 1 week pretreatment of Placebo and following 4 weeks taken to record the CIPN incidence.
Primary Outcome Measure Information:
Title
Evaluation of Oxaliplatin-induced Peripheral Neuropathy incidence rate on the 35 day in 2 arms.
Description
Peripheral neuropathy incidence rate was measured by frequency and percentage of any Oxaliplatin-induced Peripheral Neuropathy symptoms.
Time Frame
35 day after randomization
Secondary Outcome Measure Information:
Title
Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by PI on the 35 day in 2 arms.
Description
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.
Time Frame
35 day after randomization
Title
Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by subjects on the 35 day in 2 arms.
Description
Peripheral neuropathy severity by subjects was measured by Visual Analogue Scale (VAS) score (Scores range from 0 [no symptom] to 10 [worst possible symptom]).
Time Frame
35 day after randomization
Title
Evaluation of subjects quality of life difference in 2 arms on the 35 day.
Description
Quality of Life (QoL) will be measured by European Organization for Research and Treatment of Cancer quality of life questionaire C30 (EORTCQLQ-C30) questionnaire.
Time Frame
35 day after randomization
Title
Evaluation of subjects Eastern Cooperation Oncology Group-Performance Score (ECOG-PS) difference in 2 arms on the 35 day.
Description
Eastern Cooperation Oncology Group-Performance Score (ECOG-PS) will be measured by ECOG-PS score.
Time Frame
35 day after randomization
Title
Evaluation of the Adverse Events (AEs) incidence rate on 35 day in 2 arms.
Description
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.
Time Frame
Sign ICF to 35 day after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiejun WANG, MD., Ph.D
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Changzheng hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs