Phase II study of PC-SOD for Chemotherapy-induced peripheral neuropathy in ovarian cancer patients

Placebo-controlled, double-blind, randomized phase II Study of PC-SOD for Chemotherapy-induced peripheral neuropathy in ovarian cancer patients receiving TC therapy as postoperative adjuvant chemotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240306

Enrollment

Registered

2024-08-28

Start date

2024-08-30

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

Female

Inclusion criteria

Inclusion criteria: 1. female aged 18 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 glucose 4. Treatment with any investigational drug within 3 months prior to enrollment 5. Pegnancy, lactation or wish to become pregnant during study period

Design outcomes

Primary

Measure	Time frame
Incidence of CIPN	—

Contacts

Public ContactKota Ogihara

LTT Bio-Pharma Co., Ltd.

k.ogihara@ltt.co.jp+81-3-5733-7391

Outcome results

None listed

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