Clinical trial NCT02560740: 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
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Advanced Gastric Cancer
Neuropathy
Lead sponsor: SMR Biotech Co., Ltd.
Sponsor class: OTHER
First posted: 2015-09-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of Oxaliplatin-induced Peripheral Neuropathy incidence rate on the 35 day in 2 arms.
timeFrame: 35 day after randomization
Secondary outcomes:
measure: Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by PI on the 35 day in 2 arms.
timeFrame: 35 day after randomization
measure: Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by subjects on the 35 day in 2 arms.
timeFrame: 35 day after randomization
measure: Evaluation of subjects quality of life difference in 2 arms on the 35 day.
timeFrame: 35 day after randomization
measure: Evaluation of subjects Eastern Cooperation Oncology Group-Performance Score (ECOG-PS) difference in 2 arms on the 35 day.
timeFrame: 35 day after randomization
measure: Evaluation of the Adverse Events (AEs) incidence rate on 35 day in 2 arms.
timeFrame: Sign ICF to 35 day after randomization
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Jiejun WANG, MD., Ph.D
role: STUDY_DIRECTOR
References: