NIPH Clinical Trials Search

A phase 3, randomized, double-blind, placebo-controlled study of lecithinized superoxide dismutase (PC-SOD) for the prevention of chemotherapy-induced peripheral neuropathy in patients with colorectal cancer receiving mFOLFOX

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Chemotherapy-Induced Peripheral Neuropathy
Date of first enrollment	12/08/2025
Target sample size	350
Countries of recruitment
Study type	Interventional
Intervention(s)	PC-SOD is administered intravenously by drip.

Outcome(s)

Primary Outcome	Time to onset of grade 2 or higher CIPN
Secondary Outcome	Time to onset of grade 1 or higher CIPN

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients aged 18 years or older at the time of consent Patients with stage II or III colon or rectal adenocarcinoma confirmed by histopathology Patients with an ECOG performance status of 0 or 1
Exclude criteria	Patients with a history or concurrent cancer other than colon or rectal cancer Patients with a history of oxaliplatin, other platinum-based drugs, or the investigational drug Patients with sensory or motor neurological symptoms that affect CIPN evaluation, or patients with excessive vague complaints