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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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2041250081
Enrollment
350
Registered
2025-08-21
Start date
2025-08-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Interventions

PC-SOD is administered intravenously by drip.

Sponsors

Mizushima Tohru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Time to onset of grade 2 or higher CIPN—

Secondary

MeasureTime frame
Time to onset of grade 1 or higher CIPN—

Contacts

Public ContactKota Ogihara

LTT Bio-Pharma Co., Ltd.

k.ogihara@ltt.co.jp+81-3-5733-7394

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026