Phase II study of PC-SOD for chemotherapy-induced peripheral neuropathy

Placebo-controlled, double-blind, randomized phase II study of PC-SOD for chemotherapy-induced peripheral neuropathy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210466

Enrollment

Registered

2021-12-03

Start date

2022-01-19

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 (CIPN)

Interventions

PC-SOD or placebo will be given to patients as an i.v. infusion before chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female aged 20 years or older 2. Indicated for cancer chemothrapy 3. ECOG performance status of 0 or 1 4. Adequate hematological parameters 5. Adequate renal and hepatic functions 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Chemotherapy, immunotherapy, hormone therapy or radiotherapy for cancer within 12 months prior to enrollment 2. Any grade of sensory/motor neuropathy 3. Known hypersensitivity to PC-SOD, similar material of PC-SOD or xylitol 4. Treatment with any investigational drug within 3 months prior to enrollment 5. Pegnancy, lactation or possible pregnancy during study period

Design outcomes

Primary

Measure	Time frame
Incidence of CIPN	—

Contacts

Public ContactTanji Hayato

LTT Bio-Pharma Co., Ltd.

tanji@ltt.co.jp+81-3-5733-7394

Outcome results

None listed

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