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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
9
By 1 week pretreatment of PerOx Quench and following 4 weeks taken to decrease the CIPN incidence.
By 1 week pretreatment of Placebo and following 4 weeks taken to record the CIPN incidence.
Shanghai Changzheng hospital
Shanghai, Shanghai Municipality, China
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.
Time frame: 35 day after randomization
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.
Time frame: 35 day after randomization
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 \[worst possible symptom\]).
Time frame: 35 day after randomization
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.
Time frame: 35 day after randomization
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.
Time frame: 35 day after randomization
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.
Time frame: Sign ICF to 35 day after randomization
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